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)...
Drug
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...
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...
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...
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...
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...
Innovent Secures 2nd NMPA Approval for Mazdutide – First Dual GLP‑1/GCGR Therapy for Type 2 Diabetes
Innovent Biologics Ltd. (HKG: 1801) announced that its mazdutide injection (IBI362) has received its second...
Guangdong Taienkang Secures NMPA Approval for Safinamide Generic
Guangdong Taienkang Pharmaceutical Co., Ltd. (SHE: 301263) announced that the National Medical Products Administration (NMPA)...
Hengrui Pharma Secures Breakthrough Therapy Designation for SHR‑1501 in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR‑1501...
Hengrui Pharma Secures NMPA Approval for Two Novel Immune‑Inflammatory Drugs
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products...
GenSci Secures Exclusive Rights to ALK’s House Dust Mite Allergy Therapies in China
Changchun GeneScience Pharmaceutical Co., Ltd. (GenSci) announced a strategic partnership with ALK (ALKB:DC / OMX:...
Jiangsu Hengrui Secures Priority Review for Trastuzumab Rezetecan in HER2‑Positive Breast Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products...