The CEO Playbook For Biopharma In An Age Of Regulatory And Market Volatility

Biopharmaceutical leaders today are charting a course through unprecedented regulatory uncertainty and market turbulence. From shifting FDA and EMA approva...

December 16, 2025 | Tuesday | Analysis
Thermo Fisher Launches Next-Gen Chemically Defined Media to Accelerate Scalable Plasmid DNA Production

  New formulations simplify microbial bioprocessing, helping innovators scale plasmid DNA and protein production with confidence Thermo Fisher Scien...

December 16, 2025 | Tuesday | 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
Anova Launches Free AI-Powered Patient Matching Platform to Accelerate Clinical Trial Enrollment

Anova launches a free AI-enabled patient matching solution that uses proprietary algorithms to connect patients to 200,000+ open clinical trials with...

December 15, 2025 | Monday | News
Sobi Acquires Arthrosi for Up to USD 1.5 Billion, Securing Phase 3 Pozdeutinurad for Progressive Gout

Expands Sobi's pipeline with a highly differentiated new Phase 3 asset in Gout Acquisition expected to be highly accretive to...

December 15, 2025 | Monday | 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
Polpharma Biologics and Libbs Join Forces to Accelerate Biosimilar Availability for Autoimmune Diseases

Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, is thrilled to announce the si...

December 11, 2025 | Thursday | 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
Convergen Secures $10 Million Seed Financing to Advance Next-Generation Targeted Protein Degradation Therapies

Convergen, a biotech company pioneering targeted protein degradation (TPD) therapies for diseases driven by pathological protein aggregates, announced th...

December 09, 2025 | Tuesday | News
Viatris Secures $815 Million in Strategic Exit From Biocon Biologics Stake

Viatris to Receive $400 Million in Cash and $415 Million in Equity Shares of Biocon Limited Transaction Accelerates the Expiration of Biosimilars Non-Co...

December 08, 2025 | Monday | 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
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

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