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FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris

Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli®...

Phathom Pharmaceuticals Announces FDA Approval of Voquezna (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal...

2011 to 2023 Saw Increase in New GLP-1 Receptor Agonist Prescriptions

From 2011 to 2023, there was an increase in new glucagon like peptide 1 receptor agonist (GLP-1RA) prescriptions, according to a research letter published...

Study Looks at Co-Use of CYP2D6-Metabolizing Opioids, Antidepressants in Seniors

For older nursing home (NH) residents, use of CYP2D6-metabolized opioids concomitantly with CYP2D6-inhibiting antidepressants is associated with worsening...

Variety of Digital Apps Aid Mental Health Symptoms in Adults

Mindfulness-based, cognitive behavioral therapy (CBT)-based, and personalized feedback digital interventions are similarly effective in reducing mental...

TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia

EDINBURGH, Scotland, July 22, 2024. TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company"), a clinical stage biotechnology company developing platform...

Healthy Prenatal Dietary Pattern Tied to Lower Odds of Autism in Offspring

High adherence to a healthy prenatal dietary pattern is associated with reduced odds of autism diagnosis in offspring, according to a study published online...

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL (10mg/mL) Bags

London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending...

Two More Bird Flu Cases Reported in Colorado Poultry Workers

Two more cases of bird flu have been reported in Colorado poultry workers, but reassuring research finds the virus doesn't seem to be fueling silent infections,...

CDC Warns of Listeria Outbreak Tied to Deli Meats

At least 28 people have been hospitalized and two have died in a multi-state outbreak of listeria linked to deli meat, U.S. health officials warned. In...

Scientists May Have Stopped a Form of Inherited Blindness in Dogs

In her youth, Shola, an English Shepherd Dog, was a member of the Edale Mountain Rescue Team, a corps of U.K. pooches charged with helping hurt and stranded...

Dogs Can Smell Your Stress and Make Choices Based on It

Dogs can sniff out whether a human is stressed or relaxed, new research suggests, and that sensory feedback appears to influence canine emotions and choices. The...

Dental Veneers: Everything You Need to Know

Looking for a brand new smile? Many people with chipped, worn or indelibly stained teeth may ponder the possibility of veneers. They're wholly cosmetic,...

Ionis completes enrollment in pivotal trial evaluating zilganersen in people living with Alexander disease

CARLSBAD, Calif., July 18, 2024. Ionis Pharmaceuticals, Inc. announced today that it has completed enrollment in the pivotal trial of zilganersen (ION373),...

Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

(BUSINESS WIRE) July 17, 2024 -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr...

Orexo Receives a Complete Response Letter Regarding the NDA for OX124, a High-Dose Naloxone Rescue Medication in Development for Opioid Overdose

Uppsala, Sweden – July 16, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces that the company has received a complete response...

Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating Tablets Due to Mislabeling: Incorrect Strength on Product Carton

MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo...

Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

The Woodlands, Texas, July 16, 2024 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration...

GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients

GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level. Infla-650 capsules...

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Latest FDA New Drug Approvals

  • Epysqli Epysqli (eculizumab-aagh) is a complement inhibitor biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and...
  • Kisunla Kisunla (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of early symptomatic Alzheimer’s disease.
  • Ahzantive Ahzantive (aflibercept-mrbb) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of...

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Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...

More drugs in development