New Drug Applications Archive for 2023

January 3, 2023

• Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis
• Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia

January 4, 2023

• Fabre-Kramer Submits NDA Amendment for Exxua™ for Treatment of Major Depressive Disorder
• Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

January 5, 2023

• Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months

January 6, 2023

• Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)
• Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum

January 9, 2023

• Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy

January 19, 2023

• Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose

January 24, 2023

• Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date
• Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum

January 25, 2023

• Cidara Therapeutics and Melinta Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

February 3, 2023

• Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose

February 6, 2023

• Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression

February 7, 2023

• Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease

February 8, 2023

• Appili Therapeutics Announces that FDA accepts the ATI-1501 NDA

February 13, 2023

• Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date for Nyxol Eye Drops for Reversal of Mydriasis

February 20, 2023

• Astellas Provides Update on Fezolinetant New Drug Application in U.S.

February 21, 2023

• FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia
• Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review

February 22, 2023

• Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance

February 27, 2023

• Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum
• SpringWorks Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Nirogacestat for the Treatment of Adults with Desmoid Tumors

February 28, 2023

• Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil

March 2, 2023

• FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma
• Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension

March 7, 2023

• Ionis Announces FDA Acceptance of New Drug Application for Eplontersen for the Treatment of Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)

March 22, 2023

• AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application

March 23, 2023

• Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS

March 31, 2023

• HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

April 3, 2023

• CRISPR Therapeutics and Vertex Complete Submission of Rolling Biologics License Applications (BLAs) to the US FDA for exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

April 5, 2023

• Accord BioPharma Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02

April 13, 2023

• U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab

April 18, 2023

• Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for Xphozah (tenapanor)

April 21, 2023

• Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA

April 24, 2023

• bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events

May 10, 2023

• Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

May 17, 2023

• Ardelyx Announces FDA Acceptance and Six-Month Review for Resubmission of its New Drug Application of Xphozah (tenapanor)
• Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma

May 18, 2023

• Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine

May 22, 2023

• Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for Lumisight™ Optical Imaging Agent for Breast Cancer

May 23, 2023

• Phathom Pharmaceuticals Resubmits Vonoprazan Erosive GERD New Drug Application to FDA

May 26, 2023

• Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma
• Takeda and Hutchmed Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

May 30, 2023

• FDA Provides Akebia Therapeutics a Path Forward for Vadadustat
• Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
• U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

June 4, 2023

• Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

June 5, 2023

• SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA

June 6, 2023

• Vyluma Announces FDA Acceptance of New Drug Application For NVK002, Its Novel Investigational Treatment For Pediatric Myopia

June 8, 2023

• FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

June 12, 2023

• Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Vonoprazan for Erosive GERD
• Capivasertib in Combination with Faslodex Granted Priority Review in the US for Patients with Advanced HR-Positive Breast Cancer

June 15, 2023

• Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis

June 18, 2023

• GSK Announces Extension of FDA Review Period for Momelotinib

June 20, 2023

• Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat
• ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
• F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections

June 21, 2023

• Aldeyra Therapeutics Provides Regulatory Update on ADX-2191
• Cormedix Inc. Announces FDA Acceptance of Resubmission Of New Drug Application for Defencath

June 26, 2023

• UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab

June 27, 2023

• FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
• Verona Pharma Submits New Drug Application to US FDA for Ensifentrine for the Maintenance Treatment of COPD
• Allecra Therapeutics Submits New Drug Application to the U.S. FDA for Exblifep for the Treatment of Complicated Urinary Tract Infections

June 29, 2023

• Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrophy and Receives Priority Review

June 30, 2023

• Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

July 3, 2023

• Amneal Receives U.S. FDA Complete Response Letter for IPX203

July 6, 2023

• Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application

July 13, 2023

• FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility

July 17, 2023

• Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma
• Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

July 29, 2023

• Citius Pharmaceuticals, Inc. Receives A Complete Response Letter From The U.S. Food And Drug Administration (FDA) For Lymphir™ (Denileukin Diftitox) For The Treatment Of Patients With Relapsed Or Refractory Cutaneous T-Cell Lymphoma

August 4, 2023

• Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole

August 9, 2023

• Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

August 15, 2023

• Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults

August 21, 2023

• Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS
• Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application for Vonoprazan

August 22, 2023

• Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS

September 4, 2023

• FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition

September 5, 2023

• X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome

September 11, 2023

• Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) Date
• Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD
• Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

September 13, 2023

• Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis

September 14, 2023

• U.S. Food and Drug Administration Updates Prescription Drug User Fee Act (PDUFA) Action Date for Lifileucel for the Treatment of Advanced Melanoma

September 18, 2023

• Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review

September 19, 2023

• Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose
• FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study
• UCB Provides Update on U.S. Regulatory Review of Bimekizumab

September 20, 2023

• Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)

September 25, 2023

• FDA Accepts Submission to Add PH-ILD to Yutrepia™ Label

September 26, 2023

• FDA Accepts Defender Pharmaceuticals’ New Drug Application for Intranasal Scopolamine Gel
• Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa

September 27, 2023

• Alpha Cognition Announces Submission of New Drug Application to the FDA for ALPHA-1062 for Mild-to-Moderate Alzheimer’s Disease

September 28, 2023

• Akebia Therapeutics Resubmits New Drug Application to the FDA for Vadadustat
• Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia

September 29, 2023

• Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review

October 2, 2023

• Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole

October 5, 2023

• Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for Udenyca ® OnBody™

October 6, 2023

• Sun Pharma Announces US FDA Filing Acceptance of New Drug Application for Deuruxolitinib

October 12, 2023

• Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04

October 23, 2023

• ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ

October 24, 2023

• Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil

October 25, 2023

• Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease

October 26, 2023

• FDA Accepts ImmunityBio’s BLA Resubmission for N-803 plus BCG as Complete and Sets New PDUFA Date

October 30, 2023

• Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

October 31, 2023

• X4 Pharmaceuticals Announces FDA Acceptance with Priority Review of U.S. NDA for Mavorixafor in WHIM Syndrome
• CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel (exa-cel) for Severe Sickle Cell Disease

November 2, 2023

• Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA

November 17, 2023

• Merck Provides Update on FDA Advisory Committee Meeting Evaluating Gefapixant

November 27, 2023

• Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease

November 29, 2023

• Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA
• Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia

December 4, 2023

• Vanda Pharmaceuticals Announces that U.S. Food and Drug Administration Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis

December 5, 2023

• Bridgebio Pharma Announces Submission of New Drug Application to the FDA for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

December 7, 2023

• Ipsen Confirms U.S. FDA Grants Priority Review for New Drug Application for Elafibranor for the Treatment of Rare Cholestatic Liver Disease, PBC

December 11, 2023

• FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B
• FDA Accepts for Review Resubmitted NDA for TransCon PTH (palopegteriparatide) in Adult Patients with Hypoparathyroidism

December 12, 2023

• MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD

December 15, 2023

• CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis

December 18, 2023

• U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer

December 20, 2023

• Merck Provides U.S. Regulatory Update on Gefapixant

December 21, 2023

• Camurus Submits New Drug Application to the US FDA for Oclaiz for Treatment of Acromegaly

December 22, 2023

• Zealand Pharma Submits New Drug Application to the US FDA for Glepaglutide in Short Bowel Syndrome
• Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

December 26, 2023

• Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT
• Amgen Provides Regulatory Update on Status of Lumakras (sotorasib)

December 27, 2023

• Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration