Vanda Targets Mid-2026 Approval With Imsidolimab BLA for Generalized Pustular Psoriasis

Vanda Pharmaceuticals Inc.  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ims...

December 16, 2025 | Tuesday | News
RedHill Biopharma Highlights Opaganib as Potential Add-On Therapy for Venetoclax-Resistant CLL

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CL...

December 16, 2025 | Tuesday | News
Vaxxas Gains Regulatory Green Light to Manufacture HD-MAP for Clinical Trials

Australian biotechnology pioneer Vaxxas Pty Ltd, has been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture the Company&rsqu...

December 16, 2025 | Tuesday | News
J&J’s AKEEGA Wins FDA Approval After Cutting Progression Risk by More Than Half in BRCA2-Mutated mCSPC

Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (n...

December 15, 2025 | Monday | News
Savara Secures Key European Patent for MOLBREEVI as It Prepares Global Regulatory Filings

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...

December 12, 2025 | Friday | News
SOLVD Health Launches Studies To Validate GLP 1 Patient Stratification Diagnostic Platform

SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, announced the launch of two s...

December 10, 2025 | Wednesday | News
SS Innovations Submits 510(k) Application to FDA for SSi Mantra Surgical Robotic System

SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic...

December 09, 2025 | Tuesday | News
Resmed Receives FDA Clearance for Smart Comfort, the First AI-Enabled Tool for Personalized CPAP Therapy Settings

Resmed , the leading health technology company focused on sleep, breathing and care delivered in the home, announced it has received U.S. Food and Drug A...

December 09, 2025 | Tuesday | News
Pfizer Phase 3 BASIS Study Shows HYMPAVZI Delivers 93% Bleed Reduction in Hemophilia With Inhibitors

-Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolesc...

December 08, 2025 | Monday | News
Bayer Initiates Phase IIa ASSESS Trial of Investigational Antibody BAY 3401016 for Alport Syndrome

BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involve...

December 05, 2025 | Friday | News
Taiho Oncology Europe Announces UK Launch of Lytgobi (Futibatinib) for Eligible Patients With Locally Advanced or Metastatic Cholangiocarcinoma

Taiho Oncology Europe GmbH announced the UK launch of Lytgobi® (futibatinib), an irreversibly binding fibroblast growth factor receptor (FGFR) inhibi...

December 04, 2025 | Thursday | News
VANUDIS Implements Cenevo Labguru to Scale Operations and Strengthen Regulatory Readiness

VANUDIS, a biotechnology startup developing the next generation of antibody-based therapeutics, has implemented Cenevo’s Labguru solution to scale ...

December 04, 2025 | Thursday | News
Eisai and Biogen Submit Subcutaneous Lecanemab (LEQEMBI®) Application to Japan’s PMDA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachuse...

December 01, 2025 | Monday | News
Kedrion Secures EMA Orphan Drug Designation for Investigational Aceruloplasminemia Therapy

  Kedrion announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its investigational treatment for Congenita...

November 28, 2025 | Friday | News

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