Bayer Receives FDA Approval for Lynkuet, the First Dual Neurokinin Therapy for Moderate to Severe Menopausal Hot Flashes

This approval is supported by data from the Phase III OASIS clinical trial program evaluating Lynkuet for the treatment of moderate to severe hot fla...

October 27, 2025 | Monday | News
Salvat Secures FDA Approval for Clotic®, the First Targeted Therapy for Otomycosis with Orphan Drug Designation

SALVAT receives FDA approval for Clotic®, an innovative treatment for otomycosis with Orphan Drug Designation     Th...

October 22, 2025 | Wednesday | News
Cumberland Pharmaceuticals Invests $4 Million for 30% Stake and Joint Control in RedHill’s Talicia Business

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) invests $4 million in exchange for a 30% ownership stake and joint control in RedHill'...

October 21, 2025 | Tuesday | News
Genentech’s Gazyva® Receives FDA Approval for the Treatment of Lupus Nephritis in Adults

 The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus n...

October 21, 2025 | Tuesday | News
Kezar Life Sciences Initiates Strategic Review Following FDA Setback on Autoimmune Hepatitis Trial

-Kezar Life Sciences, Inc. a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated di...

October 17, 2025 | Friday | News
Bicara Therapeutics’ Ficerafusp Alfa Receives FDA Breakthrough Therapy Designation for HPV-Negative Head and Neck Cancer

Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patien...

October 14, 2025 | Tuesday | News
Neurona Therapeutics Treats First Non-MTS Subject in Phase 1/2 Trial of NRTX-1001 for Drug-Resistant Temporal Lobe Epilepsy

  - First subject received unilateral administration of NRTX-1001 in a new non-MTS cohort; no significant surgical complications or adverse events re...

October 09, 2025 | Thursday | News
Avobis Bio Earns FDA RMAT Designation for AVB-114 in Crohn’s Perianal Fistulas

Avobis Bio LLC, a clinical-stage company developing implantable cell therapies, announced  that the U.S. Food and Drug Administration ("FDA") has gr...

October 06, 2025 | Monday | News
Sitryx Therapeutics Receives FDA Clearance to Advance SYX-5219 Into Phase 1b Trial for Atopic Dermatitis

SYX-5219 is a first-in-class oral PKM2 modulator designed to drive sustained disease remission across a range of autoimmune diseases Phase 1b trial to...

October 03, 2025 | Friday | News
BMS’s BMS-986446 Receives FDA Fast Track Designation for Early Alzheimer’s Therapy

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease Fas...

October 02, 2025 | Thursday | News
Polyrizon Submits FDA Pre-Submission Package for PL-14 Allergy Blocker Nasal Spray

Polyrizon Ltd., a biotechnology company focusing on the development of intranasal products announced the submission of its full pre-submission (Pre-Sub) ...

September 22, 2025 | Monday | News
Lupin Secures U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension with 180-Day CGT Exclusivity

Global pharma major Lupin Limited  announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Ab...

September 12, 2025 | Friday | News
Greenwich LifeSciences Secures FDA Fast Track Designation for GLSI-100 in Breast Cancer

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-0...

September 11, 2025 | Thursday | News
Sanofi’s Wayrilz Wins FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

Novel treatment targets BTK through multi-immune modulation to help address root causes of ITP Approval based on LUNA 3 phase 3 study that demonstrate...

September 01, 2025 | Monday | News

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