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New Drug Approvals Archive for 2022

See also: New Indications and Dosage Forms for 2022

Quviviq (daridorexant) Tablets

Date of Approval: January 7, 2022
Company: Idorsia Ltd.
Treatment for: Insomnia

Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) for the treatment of insomnia.

Cibinqo (abrocitinib) Tablets

Date of Approval: January 14, 2022
Company: Pfizer Inc.
Treatment for: Atopic Dermatitis

Cibinqo (abrocitinib) is a Janus kinase (JAK) 1 inhibitor for the treatment of moderate-to-severe atopic dermatitis.

Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray

Date of Approval: January 13, 2022
Company: Glenmark Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis

Ryaltris (mometasone and olopatadine) nasal spray is a corticosteroid and antihistamine combination for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

Kimmtrak (tebentafusp-tebn) Injection

Date of Approval: January 25, 2022
Company: Immunocore
Treatment for: Uveal Melanoma

Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Vabysmo (faricimab-svoa) Intravitreal Injection

Date of Approval: January 28, 2022
Company: Genentech
Treatment for: Macular Degeneration, Diabetic Macular Edema, Macular Edema

Vabysmo (faricimab-svoa) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

Spikevax (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection

Date of Approval: January 31, 2022
Company: Moderna, Inc.
Treatment for: Prevention of COVID-19

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula and Moderna COVID-19 Vaccine 2023-2024 Formula are mRNA vaccines for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Enjaymo (sutimlimab-jome) Injection

Date of Approval: February 4, 2022
Company: Sanofi
Treatment for: Cold Agglutinin Disease

Enjaymo (sutimlimab-jome) is a classical complement inhibitor indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).

Fleqsuvy (baclofen) Oral Suspension

Date of Approval: February 4, 2022
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Spasticity

Fleqsuvy (baclofen) is an oral suspension formulation of baclofen for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Pyrukynd (mitapivat) Tablets

Date of Approval: February 17, 2022
Company: Agios Pharmaceuticals, Inc.
Treatment for: Pyruvate Kinase Deficiency

Pyrukynd (mitapivat) is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

NephroScan (technetium Tc 99m succimer) Injection Kit

Date of Approval: February 22, 2022
Treatment for: Diagnosis and Investigation

NephroScan (kit for the preparation of technetium Tc 99m succimer injection) is a radioactive diagnostic agent indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders.

Carvykti (ciltacabtagene autoleucel) Suspension for Intravenous Infusion

Date of Approval: February 28, 2022
Company: Janssen Pharmaceutical Companies
Treatment for: Multiple Myeloma

Carvykti (ciltacabtagene autoleucel) is a BCMA-directed CAR-T immunotherapy for the treatment of patients with relapsed or refractory multiple myeloma.

Norliqva (amlodipine besylate) Oral Solution

Date of Approval: February 24, 2022
Company: CMP Pharma, Inc.
Treatment for: High Blood Pressure, Coronary Artery Disease, Angina

Norliqva (amlodipine besylate) is an oral solution formulation of the approved calcium channel blocker amlodipine for the treatment of hypertension and angina in patients with coronary artery disease.

Vonjo (pacritinib) Capsules

Date of Approval: February 28, 2022
Company: CTI BioPharma Corp.
Treatment for: Myelofibrosis

Vonjo (pacritinib) is a JAK2/FLT3 multikinase inhibitor for the treatment of myelofibrosis patients with severe thrombocytopenia.

Releuko (filgrastim-ayow) Injection

Date of Approval: February 25, 2022
Company: Kashiv BioSciences, LLC
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia

Releuko (filgrastim-ayow) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.

Adlarity (donepezil) Transdermal System

Date of Approval: March 11, 2022
Company: Corium, Inc.
Treatment for: Alzheimer's Disease

Adlarity (donepezil transdermal system) is a once-weekly transdermal formulation of the approved acetylcholinesterase inhibitor donepezil indicated for the treatment of Alzheimer’s type dementia.

Nasonex 24HR Allergy (mometasone furoate monohydrate) Nasal Spray

Date of Approval: March 17, 2022
Company: Perrigo Company plc
Treatment for: Allergic Rhinitis

Nasonex 24HR Allergy (mometasone furoate monohydrate) is a corticosteroid nasal spray available over-the-counter for the temporary relief of the symptoms of hayfever or other upper respiratory allergies.

Ztalmy (ganaxolone) Oral Suspension

Date of Approval: March 18, 2022
Company: Marinus Pharmaceuticals, Inc.
Treatment for: CDKL5 Deficiency Disorder

Ztalmy (ganaxolone) is neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Opdualag (nivolumab and relatlimab-rmbw) Injection

Date of Approval: March 18, 2022
Company: Bristol Myers Squibb
Treatment for: Melanoma

Opdualag (nivolumab and relatlimab-rmbw) is programmed death receptor-1 (PD-1) blocking antibody and lymphocyte activation gene-3 (LAG-3) blocking antibody combination indicated for the treatment of unresectable or metastatic melanoma.

Xelstrym (dextroamphetamine) Transdermal System

Date of Approval: March 22, 2022
Company: Noven Pharmaceuticals, Inc.
Treatment for: ADHD

Xelstrym (dextroamphetamine) transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years and older.

Locametz (gallium Ga 68 gozetotide) Injection

Date of Approval: March 23, 2022
Company: Novartis Pharmaceuticals Corporation
Treatment for: Positron Emission Tomography Imaging

Locametz (kit for the preparation of gallium Ga 68 gozetotide injection) after radiolabeling with gallium-68, is a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.

Pluvicto (lutetium lu 177 vipivotide tetraxetan) Injection

Date of Approval: March 23, 2022
Company: Novartis
Treatment for: Prostate Cancer

Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent indicated for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Tlando (testosterone) Capsules

Date of Approval: March 28, 2022
Company: Antares Pharma, Inc.
Treatment for: Hypogonadism, Male

Tlando (testosterone) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Hyftor (sirolimus) Topical Gel

Date of Approval: March 22, 2022
Company: Nobelpharma America, LLC
Treatment for: Facial Angiofibroma Associated with Tuberous Sclerosis

Hyftor (sirolimus topical gel) is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.

Vijoice (alpelisib) Tablets

Date of Approval: April 5, 2022
Company: Novartis
Treatment for: PIK3CA-Related Overgrowth Spectrum

Vijoice (alpelisib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Igalmi (dexmedetomidine) Sublingual Film

Date of Approval: April 5, 2022
Company: BioXcel Therapeutics, Inc.
Treatment for: Agitation

Igalmi (dexmedetomidine) is a sublingual film formulation of the approved alpha2-adrenergic receptor agonist dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Alymsys (bevacizumab-maly) Injection

Date of Approval: April 13, 2022
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Epsolay (benzoyl peroxide) Cream

Date of Approval: April 22, 2022
Company: Sol-Gel Technologies, Ltd.
Treatment for: Rosacea

Epsolay (benzoyl peroxide) is a topical oxidizing agent for the treatment of inflammatory lesions of rosacea in adults.

Vivjoa (oteseconazole) Capsules

Date of Approval: April 26, 2022
Company: Mycovia Pharmaceuticals, Inc.
Treatment for: Vaginal Yeast Infection

Vivjoa (oteseconazole) is an oral azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Camzyos (mavacamten) Capsules

Date of Approval: April 28, 2022
Company: Bristol Myers Squibb
Treatment for: Hypertrophic Cardiomyopathy

Camzyos (mavacamten) is a first-in-class cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Cuvrior (trientine tetrahydrochloride) Tablets

Date of Approval: April 28, 2022
Company: Orphalan SA
Treatment for: Wilson's Disease

Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.

Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) Co-Packaged Capsules and Tablets

Date of Approval: May 3, 2022
Company: Phathom Pharmaceuticals, Inc.
Treatment for: Helicobacter Pylori Infection

Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) is a co-packaged product containing amoxicillin (penicillin class antibacterial), clarithromycin (macrolide antimicrobial), and vonoprazan (potassium-competitive acid blocker (PCAB)) indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

Radicava ORS (edaravone) Oral Suspension

Date of Approval: May 12, 2022
Company: Mitsubishi Tanabe Pharma Corporation
Treatment for: Amyotrophic Lateral Sclerosis

Radicava ORS is a free radical scavenger indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Mounjaro (tirzepatide) Injection

Date of Approval: May 13, 2022
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 2

Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Vtama (tapinarof) Cream

Date of Approval: May 23, 2022
Company: Dermavant Sciences
Treatment for: Plaque Psoriasis

Vtama (tapinarof) is a topical aryl hydrocarbon receptor (AhR) modulating agent indicated for the treatment of plaque psoriasis in adults.

Fylnetra (pegfilgrastim-pbbk) Injection

Date of Approval: May 26, 2022
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Fylnetra (pegfilgrastim-pbbk) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of neutropenia in patients undergoing chemotherapy.

Priorix (measles, mumps, and rubella virus vaccine, live) Injection

Date of Approval: June 3, 2022
Company: GSK
Treatment for: Measles Prophylaxis, Mumps Prophylaxis, Rubella Prophylaxis

Priorix (measles, mumps, and rubella virus vaccine, live) is a live attenuated vaccine for use in active immunization against infection by measles, mumps and rubella (MMR).

Amvuttra (vutrisiran) Injection

Date of Approval: June 13, 2022
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Amyloidosis

Amvuttra (vutrisiran) is an RNAi therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

Bludigo (indigotindisulfonate sodium) Injection

Date of Approval: July 8, 2022
Company: Provepharm
Treatment for: Diagnosis and Investigation

Bludigo (indigotindisulfonate sodium) is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

Zonisade (zonisamide) Oral Suspension

Date of Approval: July 15, 2022
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Seizures

Zonisade (zonisamide) is an oral suspension formulation of the approved anticonvulsant zonisamide indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.

Zoryve (roflumilast) Cream and Foam

Date of Approval: July 29, 2022
Company: Arcutis Biotherapeutics, Inc.
Treatment for: Plaque Psoriasis, Seborrheic Dermatitis

Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of plaque psoriasis (cream formulation) and seborrheic dermatitis (foam formulation).

Kyzatrex (testosterone undecanoate) Capsules

Date of Approval: July 27, 2022
Company: Marius Pharmaceuticals
Treatment for: Hypogonadism, Male

Kyzatrex (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

Cimerli (ranibizumab-eqrn) Intravitreal Injection

Date of Approval: August 2, 2022
Company: Coherus BioSciences, Inc.
Treatment for: Macular Degeneration, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy, Myopic Choroidal Neovascularization

Cimerli (ranibizumab-eqrn) is a vascular endothelial growth factor (VEGF) inhibitor, interchangeable biosimilar to Lucentis indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

Zynteglo (betibeglogene autotemcel) Suspension for Intravenous Infusion

Date of Approval: August 17, 2022
Company: Bluebird Bio, Inc.
Treatment for: Beta Thalassemia

Zynteglo (betibeglogene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.

Auvelity (dextromethorphan and bupropion) Extended-Release Tablets - formerly AXS-05

Date of Approval: August 18, 2022
Company: Axsome Therapeutics, Inc.
Treatment for: Major Depressive Disorder

Auvelity (dextromethorphan and bupropion) is an NMDA receptor antagonist for the treatment of major depressive disorder (MDD) in adults.

Xenpozyme (olipudase alfa) Lyophilized Powder for Injection

Date of Approval: August 31, 2022
Company: Sanofi
Treatment for: Acid Sphingomyelinase Deficiency

Xenpozyme (olipudase alfa-rpcp) is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD).

Konvomep (omeprazole and sodium bicarbonate) Powder for Oral Suspension

Date of Approval: August 30, 2022
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Stomach Ulcer, Gastrointestinal Hemorrhage

Konvomep (omeprazole and sodium bicarbonate) is an oral liquid formulation of the proton pump inhibitor (PPI) omeprazole and sodium bicarbonate combination indicated for the treatment of active benign gastric ulcer, and reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.

Spevigo (spesolimab-sbzo) Injection

Date of Approval: September 1, 2022
Company: Boehringer Ingelheim
Treatment for: Generalized Pustular Psoriasis

Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis.

Stimufend (pegfilgrastim-fpgk) Injection

Date of Approval: September 1, 2022
Company: Fresenius Kabi
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation

Stimufend (pegfilgrastim-fpgk) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) used to reduce the duration of febrile neutropenia in patients treated with chemotherapy and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Daxxify (daxibotulinumtoxinA-lanm) Lyophilized Powder for Injection

Date of Approval: September 7, 2022
Company: Revance Therapeutics, Inc.
Treatment for: Glabellar Lines, Cervical Dystonia

Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent for the temporary improvement of glabellar (frown) lines and the treatment of cervical dystonia.

Sotyktu (deucravacitinib) Tablets

Date of Approval: September 9, 2022
Company: Bristol Myers Squibb
Treatment for: Plaque Psoriasis

Sotyktu (deucravacitinib) is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Rolvedon (eflapegrastim-xnst) Injection - formerly Rolontis

Date of Approval: September 9, 2022
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Rolvedon (eflapegrastim-xnst) is a leukocyte growth factor used to reduce the incidence of infection due to chemotherapy-induced neutropenia.

Terlivaz (terlipressin) Lyophilized Powder for Injection

Date of Approval: September 14, 2022
Company: Mallinckrodt plc
Treatment for: Hepatorenal Syndrome

Terlivaz (terlipressin) is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.

Aponvie (aprepitant) Injection - formerly HTX-019

Date of Approval: September 16, 2022
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Postoperative

Aponvie (aprepitant) is an intravenous formulation of the approved antiemetic aprepitant indicated for the prevention of postoperative nausea and vomiting (PONV).

Skysona (elivaldogene autotemcel) Suspension for Intravenous Infusion

Date of Approval: September 16, 2022
Company: bluebird bio, Inc.
Treatment for: Cerebral Adrenoleukodystrophy

Skysona (elivaldogene autotemcel) is a one-time gene therapy used to treat the underlying cause of cerebral adrenoleukodystrophy (CALD).

Elucirem (gadopiclenol) Injection

Date of Approval: September 21, 2022
Company: Guerbet
Treatment for: Diagnosis and Investigation

Elucirem (gadopiclenol) is a macrocyclic gadolinium-based contrast agent (GBCA) for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the CNS and the body.

Pedmark (sodium thiosulfate) Injection

Date of Approval: September 20, 2022
Company: Fennec Pharmaceuticals Inc.
Treatment for: Prevention of Cisplatin-Induced Ototoxicity

Pedmark (sodium thiosulfate) is a cisplatin neutralizing agent used to reduce the risk of ototoxicity associated with cisplatin chemotherapy.

Omlonti (omidenepag isopropyl) Ophthalmic Solution

Date of Approval: September 22, 2022
Company: Santen Inc.
Treatment for: Glaucoma/Intraocular Hypertension

Omlonti (omidenepag isopropyl) is a relatively selective prostaglandin E2 (EP2) receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Iheezo (chloroprocaine hydrochloride) Ophthalmic Gel

Date of Approval: September 27, 2022
Company: Harrow
Treatment for: Ocular Surface Anesthesia

Iheezo (chloroprocaine hydrochloride) is an ester anesthetic indicated for ocular surface anesthesia.

Vegzelma (bevacizumab-adcd) Injection

Date of Approval: September 27, 2022
Company: Celltrion USA
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Vegzelma (bevacizumab-adcd) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Relyvrio (sodium phenylbutyrate and taurursodiol) Powder for Oral Suspension - formerly AMX0035

Date of Approval: September 29, 2022
Company: Amylyx Pharmaceuticals, Inc.
Treatment for: Amyotrophic Lateral Sclerosis

Relyvrio (sodium phenylbutyrate and taurursodiol) is a neuroprotective therapy for the treatment of amyotrophic lateral sclerosis (ALS).

Lytgobi (futibatinib) Tablets

Date of Approval: September 30, 2022
Company: Taiho Oncology, Inc.
Treatment for: Cholangiocarcinoma

Lytgobi (futibatinib) is an irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 for the treatment of intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Furoscix (furosemide) Injection

Date of Approval: October 7, 2022
Company: scPharmaceuticals, Inc.
Treatment for: Heart Failure

Furoscix (furosemide) is a loop diuretic indicated for the at-home treatment of congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure.

Imjudo (tremelimumab-actl) Injection

Date of Approval: October 21, 2022
Company: AstraZeneca
Treatment for: Hepatocellular Carcinoma, Non-Small Cell Lung Cancer

Imjudo (tremelimumab-actl) is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC), and in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

Tecvayli (teclistamab-cqyv) Injection

Date of Approval: October 25, 2022
Company: Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma

Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Elahere (mirvetuximab soravtansine-gynx) Injection

Date of Approval: November 14, 2022
Company: ImmunoGen, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Tzield (teplizumab-mzwv) Injection

Date of Approval: November 17, 2022
Company: Provention Bio, Inc.
Treatment for: Delaying the Onset of Stage 3 Type 1 Diabetes

Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

Sezaby (phenobarbital sodium) Powder for Injection

Date of Approval: November 17, 2022
Company: Sun Pharmaceutical Industries Limited
Treatment for: Neonatal Seizures

Sezaby (phenobarbital sodium) is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.

Hemgenix (etranacogene dezaparvovec-drlb) Suspension for Intravenous Infusion

Date of Approval: November 22, 2022
Company: CSL
Treatment for: Hemophilia B

Hemgenix (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with hemophilia B.

Rebyota (fecal microbiota, live-jslm) Suspension for Rectal Use - formerly RBX2660

Date of Approval: November 30, 2022
Company: Ferring Pharmaceuticals Inc.
Treatment for: Prevention of Recurrent Clostridioides difficile Infection

Rebyota (fecal microbiota, live-jslm) is a microbiota-based live biotherapeutic indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

Rezlidhia (olutasidenib) Capsules

Date of Approval: December 1, 2022
Company: Forma Therapeutics
Treatment for: Acute Myeloid Leukemia

Rezlidhia (olutasidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

Krazati (adagrasib) Tablets

Date of Approval: December 12, 2022
Company: Mirati Therapeutics, Inc.
Treatment for: Non-Small Cell Lung Cancer

Krazati (adagrasib) is a small-molecule inhibitor of KRAS G12C for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Iyuzeh (latanoprost) Ophthalmic Solution

Date of Approval: December 13, 2022
Company: Thea Pharma, Inc.
Treatment for: Intraocular Hypertension, Glaucoma, Open Angle

Iyuzeh (latanoprost) is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Idacio (adalimumab-aacf) Injection

Date of Approval: December 13, 2022
Company: Fresenius Kabi
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Idacio (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Adstiladrin (nadofaragene firadenovec-vncg) Suspension for Intravesical Use

Date of Approval: December 16, 2022
Company: Ferring Pharmaceuticals
Treatment for: Bladder Cancer

Adstiladrin (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Sunlenca (lenacapavir) Injection and Tablets

Date of Approval: December 22, 2022
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Sunlenca (lenacapavir) is a long-acting HIV-1 capsid inhibitor for use in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

Lunsumio (mosunetuzumab-axgb) Injection

Date of Approval: December 22, 2022
Company: Genentech
Treatment for: Follicular Lymphoma

Lunsumio (mosunetuzumab-axgb) is a bispecific CD20-directed CD3 T-cell engager for the treatment of relapsed or refractory follicular lymphoma.

Olpruva (sodium phenylbutyrate) for Oral Suspension - formerly ACER-001

Date of Approval: December 22, 2022
Company: Acer Therapeutics Inc.
Treatment for: Urea Cycle Disorders

Olpruva (sodium phenylbutyrate) is a nitrogen-binding agent for the treatment of patients with urea cycle disorders (UCDs).

Xenoview (xenon Xe 129 hyperpolarized) for Oral Inhalation

Date of Approval: December 23, 2022
Company: Polarean Imaging plc
Treatment for: Diagnosis and Investigation, Imaging of Lung

Xenoview (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Briumvi (ublituximab-xiiy) Injection

Date of Approval: December 28, 2022
Company: TG Therapeutics, Inc.
Treatment for: Multiple Sclerosis

Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

NexoBrid (anacaulase-bcdb) for Topical Gel

Date of Approval: December 28, 2022
Company: MediWound Ltd.
Treatment for: Thermal Burn

NexoBrid (anacaulase-bcdb) is a concentrate of proteolytic enzymes indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.

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