FDA Issues Draft Guidance on Plausible Mechanism Framework – Accelerates Approval Pathway for Individualized Genetic Therapies
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the...
Gilead Sciences to Acquire Arcellx for $7.8B – Bolsters CAR‑T Pipeline with BCMA‑Targeted Anito‑cel
Gilead Sciences Inc. (NASDAQ: GILD) announced a definitive agreement to acquire Arcellx Inc. (NASDAQ: ACLX) for USD 115.00...
Pfizer Partners with Sciwind Biosciences for Ecnoglutide China Rights – $495M Deal Marks Metabolic Market Entry
Pfizer Inc. (NYSE: PFE) has entered into an exclusive commercialization agreement with Sciwind Biosciences Co., Ltd....
Merck Restructures Human Health into Oncology and Specialty Units – Appoints Oosthuizen and Foard to Lead New Divisions
Merck & Co. (MSD, NYSE: MRK) announced a major organizational restructuring of its Human Health division,...
Sino Biopharma’s Benmelstobart Secures Fourth NMPA Approval for Stage III NSCLC – Expanding PD‑L1 Franchise in China
Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart, a Category 1 innovative humanized anti‑PD‑L1 monoclonal antibody...
Mabworks’ Obexelimab β Wins NMPA Approval as First Domestic NMOSD Therapy
Beijing Mabworks Biotech Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved...
Findcure Bio Raises $14.5 Million Series B to Advance Radiopharmaceutical Platform
Fannkoer Biotech (Zhongshan) Co., Ltd. announced the completion of a Series B financing round exceeding...
Siemens Healthineers Deepens Mayo Clinic Partnership on AI Neurology and Precision Oncology
Siemens Healthineers AG (ETR: SHL) and Mayo Clinic announced an expansion of their strategic partnership, targeting...
VivaVision Biotech Files Hong Kong IPO to Advance Ophthalmology Pipeline
VivaVision Biotech (Zhejiang) Co., Ltd., an ophthalmology-focused biotech company founded in 2016, has submitted its...
Astellas’ VENTANA CLDN18 Assay Wins NMPA Approval as First Companion Diagnostic for VYLOY
Astellas Pharma Inc. (TYO: 4503) announced that its VENTANA CLDN18 (43-14A) Assay has received approval...
Genhouse Bio Partners with Gilead on $1.5 Billion Synthetic Lethal Cancer Project GH31
Genhouse Bio (Suzhou) Co., Ltd., a Viva Biotech-incubated company, announced a global collaboration agreement with...
3SBio’s Amdokitug Wins NMPA Approval for Moderate-to-Severe Plaque Psoriasis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Bio-Thera’s Gotenfia Wins European Approval as Simponi Biosimilar
Bio-Thera Solutions Inc. (SHA: 688177) announced that the European Commission (EC) has approved Gotenfia (BAT2506), its...
First Imaging Raises $14.5 Million to Advance AI-Powered Intraoperative Imaging
First Imaging, a Nantong-based medical imaging equipment provider, has closed a Series B+ financing round...
CARsgen Therapeutics to Invest $54 Million in Shanghai CAR-T Manufacturing Facility
CARsgen Therapeutics Holdings Ltd. (HKG: 2171), a China-based CAR-T cell therapy specialist, announced plans to invest...
GSK Reports 7% Revenue Growth to $44.7 Billion in 2025; Oncology Surges 43%
GlaxoSmithKline plc (GSK, NYSE: GSK) delivered strong 2025 financial results, with total revenues rising 7% in...
Novocure’s Optune Pax Wins FDA Approval for Pancreatic Cancer; Zai Lab China Rights in Play
Novocure Ltd. (NASDAQ: NVCR), Zai Lab Ltd.’s (NASDAQ: ZLAB, HKG: 9688) Swiss oncology partner, announced FDA clearance for...
China Medical System Licenses Teikoku’s Lidoderm for Postherpetic Neuralgia in China
China Medical System Holdings Limited (HKG: 0867) announced a licensing agreement with Teikoku Seiyaku Co., Ltd.,...
Organon Reports 2025 Revenue Decline to $6.2 Billion; JADA Sale and Portfolio Pressures Weigh
Organon & Co. (NYSE: OGN) announced fourth quarter and full-year 2025 financial results, with total revenue...
Salubris Pharma Files Hong Kong IPO for Secondary Listing to Expand Cardiorenal Metabolic Franchise
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294), a pioneer in cardiorenal metabolic syndrome treatment in China,...