Sarepta Receives FDA Approval to Initiate Cohort 8 Evaluating Sirolimus With ELEVIDYS in Non-Ambulant Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to be...

November 26, 2025 | Wednesday | News
Aidoc Sets New Benchmark in Clinical AI With Foundation Model FDA Submission and 100M Real-World Cases

Aidoc, the global leader in clinical AI with the most FDA-cleared CAD solutions,  announced a major milestone: the completion of its pivotal study a...

November 26, 2025 | Wednesday | News
Avenzo Therapeutics Receives FDA Fast Track Designation for AVZO-103 in Urothelial Cancer

-Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the U....

November 25, 2025 | Tuesday | News
Thermo Fisher’s Oncomine Dx Target Test Gains FDA Approval as CDx for Bayer’s Newly Approved HYRNUO™

  Test will serve as a companion diagnostic for Bayer’s HYRNUO™ (sevabertinib) to identify patients with NSCLC eligible for HER2-targeted...

November 20, 2025 | Thursday | News
Alvotech and Advanz Pharma Secure EC Approval for Gobivaz®, the First Simponi® (golimumab) Biosimilar in Europe

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Adva...

November 21, 2025 | Friday | News
Oncolytics Biotech Gains FDA Agreement on Pivotal Study Design for Pelareorep in First-Line Metastatic Pancreatic Cancer

Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026 Trial design allows flex...

November 20, 2025 | Thursday | News
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

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