FDA Announces Flexible CMC Pathway for Cell and Gene Therapies to Accelerate Development
The FDA’s Center for Biologics Evaluation and Research (CBER) announced a flexible, lifecycle‑based approach to...
Huadong Medicine’s DR10624 Wins Breakthrough Designation for Severe Hypertriglyceridemia
Huadong Medicine Co., Ltd (SHE: 000963) announced that DR10624, a long‑acting triple‑target agonist developed by...
Dongcheng Pharma’s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA)...
Novartis to Build $23 Billion RLT Facility in Florida, Expanding Cancer Therapy Capacity
Novartis AG (NYSE: NVS) announced plans to construct its fourth radiopharmaceutical therapy (RLT) manufacturing facility in...
Pierre Fabre Partners with Iktos on AI-Driven Oncology Drug Discovery
Pierre Fabre Laboratories announced a comprehensive drug discovery collaboration with French AI specialist Iktos to...
NHSA Launches Personal Healthcare Insurance Cloud Pilot Program
China’s National Healthcare Security Administration (NHSA) issued a notice inviting applications for pilot projects to...
China Expands Medical Insurance Personal Account Pooling Nationwide
China’s National Healthcare Security Administration (NHSA) and Ministry of Finance (MoF) jointly issued the “Notice...
Haisco Licenses COPD Drug HSK39004 to AirNexis for $1.06 Billion
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced it has granted AirNexis Therapeutics exclusive worldwide...
Novartis Secures Exclusive Rights to Zonsen PepLib’s Radioligand Asset
Novartis (NYSE: NVS) announced it has secured exclusive global rights to an undisclosed peptide asset...
Boan Biosimilar Prolia Wins Bolivia Approval, Targets Global Markets
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that BA6101, its biosimilar version of Amgen’s...
Johnson & Johnson Strikes Tariff Exemption Deal with Trump Administration
Johnson & Johnson (J&J, NYSE: JNJ) announced a voluntary agreement with the Trump Administration to...
Hybio Pharmaceutical Licenses Semaglutide to Vitamedic for Brazil Market
Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced an out‑licensing agreement with Vitamedic Health Nutraceuticals (Brazil),...
Merck in Talks to Acquire Revolution Medicines for $28‑32 Billion in Oncology Push
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) is reportedly in advanced negotiations to acquire Revolution Medicines...
Genrix Bio’s GR1803 NDA Accepted for BCMA-Targeted Multiple Myeloma Therapy
Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) announced that the conditional New Drug Application (NDA)...
RemeGen’s RC48 Wins Fourth Breakthrough Therapy Designation for Gastric Cancer Combo
RemeGen Ltd (SHA: 688331, HKG: 9995) announced that its core product, Disitamab Vedotin (RC48/Aidixi), has...
Merck Initiates Phase 3 Trial for Calderasib + KEYTRUDA QLEX in KRAS G12C NSCLC
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of KANDLELIT‑007, a Phase 3 clinical...
Takeda Licenses Halozyme’s ENHANZE Technology for Vedolizumab in Global Deal
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) announced a global collaboration and license agreement...
Hansoh Pharmaceutical’s Ameile Wins Fifth NMPA Indication for EGFR‑Mutated NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that its core product, Ameile (almonertinib), has...
Eisai China and Xuanwu Hospital Forge Strategic Cooperation for Drug R&D
Eisai (TYO: 4523) China and Xuanwu Hospital of Capital Medical University officially signed a Strategic...
Imunopharm’s IM19 CAR‑T Wins NMPA IND for Second‑Line NHL Therapy
Beijing Imunopharm Technology Co., Ltd. announced that its independently developed CD19‑targeted CAR‑T cell therapy, IM19,...