Symbiosis Manufactures First 10,000-Vial Batch at New Stirling Sterile Fill-Finish Facility

Symbiosis Pharmaceutical Services (Symbiosis), a leading sterile fill finish contract manufacturing organisation (CMO), has manufactured their first 10,0...

December 24, 2025 | Wednesday | News
FNIH Secures FDA Qualification of Hip Bone Mineral Density as Surrogate Endpoint in Osteoporosis Trials

Measuring change in bone mineral density, rather than fracture occurrence, promises to speed development of new drugs to treat osteoporosis. FNIH Bi...

December 22, 2025 | Monday | News
SynaptixBio Backs FDA Priority Review Voucher Renewal as Critical Lifeline for Rare Disease Innovation

SynaptixBio, the only company licensed to commercialise a treatment for a rare, deadly disease, says the Priority Review Voucher scheme is a lifeline for...

December 22, 2025 | Monday | News
Minghui Pharma Secures FDA IND Clearance to Launch Global Phase 3 Trials of MHB018A in Thyroid Eye Disease

Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announc...

December 16, 2025 | Tuesday | News
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
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
Prilenia and Ferrer Receive FDA Clearance to Begin 500-Patient Pivotal Phase 3 ALS Study of Pridopidine

Prilenia Therapeutics B.V. and Ferrer  announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, r...

December 12, 2025 | Friday | News
China Approves InnoCare’s Breakthrough TRK Inhibitor Zurletrectinib for Adult and Adolescent Solid Tumors

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced that its next-generation TRK inhibitor, zurletrectinib (ICP-72...

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
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
Incyte Announces FDA Breakthrough Therapy Designation for INCA033989 for Essential Thrombocythemia with Type 1 CALR Mutation

Incyte  announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class muta...

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
Insulet Receives FDA Clearance for Major Omnipod 5 Algorithm Upgrade Featuring New 100 mg/dL Target Glucose Setting

New 100 mg/dL Target Glucose setting offers more customization and tighter glucose management. Enhanced algorithm helps users remain in Automated Mo...

December 05, 2025 | Friday | News
Roche’s 15-Minute PCR Test for Whooping Cough Receives FDA Clearance and CLIA Waiver

The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications ...

December 02, 2025 | Tuesday | News

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