Sarepta Announces Prescribing Information Update for ELEVIDYS Gene Therapy

Sarepta Therapeutics, Inc. the leader in precision genetic medicine for rare diseases,  announced an update to the prescribing information for ELEVI...

November 17, 2025 | Monday | News
Amneal Earns FDA Approval for First Generic Iohexol, Targeting $652M U.S. Market

Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FD...

November 17, 2025 | Monday | News
Thermo Fisher Secures FDA Clearance for First-of-Its-Kind Automated System to Transform Multiple Myeloma Diagnosis

First-of-its-kind, automated system delivers increased sensitivity, specific identification of disease markers and improved laboratory workflow to suppor...

November 13, 2025 | Thursday | Regulatory
March Biosciences Receives FDA RMAT Designation for MB-105 CAR-T in T-Cell Lymphoma

- March Biosciences (March Bio), a clinical stage biotechnology company developing cell therapies for hard-to-treat cancers,  announced that the U.S...

November 12, 2025 | Wednesday | News
LISCure Biosciences Initiates Global Phase 2 Trial of LB-P8 in Primary Sclerosing Cholangitis

 LISCure Biosciences ("LISCure"), a clinical-stage biopharmaceutical company, announced the initiation of patient dosing in a global Phase 2 cl...

November 11, 2025 | Tuesday | News
Armata Pharmaceuticals Commissions State-of-the-Art cGMP Manufacturing Facility in Los Angeles

Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high...

November 11, 2025 | Tuesday | News
Boehringer Ingelheim Receives FDA National Priority Voucher for HERNEXEOS® in First-Line HER2-Mutant NSCLC

  The U.S. Food & Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNPV) for HERNEXEOS® (zongertinib tablets...

November 10, 2025 | Monday | News
Dupixent Delivers First Positive Phase 3 Results in Allergic Fungal Rhinosinusitis

Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal cong...

November 10, 2025 | Monday | News
Jupiter Neurosciences Receives FDA IND Clearance to Initiate Phase 2a Trial of JOTROL™ in Parkinson’s Disease

Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based therapeutic pla...

November 06, 2025 | Thursday | News
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

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