Stealth BioTherapeutics Receives FDA Accelerated Approval for Forzinity in Barth Syndrome
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Stealth BioTherapeutics’ Forzinity (elamipretide)...
September 2025
China Drug Procurement: Centralized Rules Shape 11th Round Of VBP
The Joint Procurement Office of the National Healthcare Security Administration (NHSA) published the definitive rules...
Genrix Bio Secures Exclusive Deal for Vecantoxatug and Silevimig with CMS
China‑based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) and China Medical System Holdings Ltd....
Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...
Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its Phase III evERA trial has met both co‑primary...
Shanghai Sanyou Medical’s Agloe Robot Enters Chinese NMPA Special Review for Innovative Spine Devices
Shanghai Sanyou Medical Co., Ltd. (SHA: 688085) announced that its affiliate Agloe Medical Technologies has...
Eisai Secures FDA Fast Track for Etalanetug, a Tau Antibody Targeting MTBR
Eisai Co. Ltd. (TYO: 4523) announced today that its investigational tau‑protein antibody etalanetug (E2814) has...
Pfizer to Acquire Metsera for $4.9 B, Expanding Its Obesity & Cardiometabolic Pipeline
Pfizer Inc. (NYSE: PFE) announced today that it will acquire Metsera, Inc. (NASDAQ: MTSR), a...
Youcare Pharma Secures FDA Approval for YKYY013, a Novel siRNA Therapy for Chronic Hepatitis B
Youcare Pharmaceutical Group (SHA: 688658) announced that the U.S. Food and Drug Administration (FDA) has...
National Healthcare Security Administration Announces Nationwide Pilot for Real‑World Medical‑Insurance Value Evaluation
The National Healthcare Security Administration (NHSA) today issued a notice outlining a multi‑city pilot program...
Huadong Medicine Secures FDA IND Approval for HDM2017 ADC
Huadong Medicine Co., Ltd. (SHE: 000963) announced today that the U.S. Food and Drug Administration...
Sichuan Kelun‑Biotech’s A400 Receives NDA Acceptance in China
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation...
Visen Pharmaceuticals Secures Hainan Approval for Palopegteriparatide
Visen Pharmaceuticals (HKG: 2561) announced today that its innovative drug palopegteriparatide (TransCon PTH) has received official...
Stone Pharmaceuticals Launches CS2009 Phase II Trial in Australia
CStone Pharmaceuticals (HKG: 2616) announced today that the first patient has been dosed in Australia...
Nanjing Leads Biolabs Secures FDA IND for LBL‑047, a First‑In‑Class Bispecific Fusion Protein
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced today that the U.S. Food and Drug...
China’s Insilico, Mabwell, and Chemexpress Forge AI‑Driven ADC Collaboration
Insilico Medicine, a global leader in generative AI‑driven drug discovery, announced a strategic partnership with...
NHSA Completes 2025 Drug Negotiation Review; CAR‑T Therapies Clear the Hurdle
The National Healthcare Security Administration (NHSA) announced today that the expert review for the 2025...
Shenzhen Salubris Submits NMPA NDA for SAL003, a Once‑Monthly Anti‑PCSK9 Biologic
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that it has filed a New Drug...
Biogen Acquires Alcyone Therapeutics to Drive ThecaFlex DRx Implant Development
Biogen Inc. (NASDAQ: BIIB) announced the acquisition of Massachusetts‑based Alcyone Therapeutics. The deal centers on...
Henlius Organon Secure EU Marketing Approval for BILDYOS and BILPREVDA Denosumab Biosimilars
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Commission...