FDA Approves Zycubo as First Therapy for Pediatric Menkes Disease, Targeting Ultra‑Rare Copper Deficiency Disorder
The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, the first...
Drug
BMS’s Camzyos Meets Primary Endpoint in Phase III SCOUT-HCM Study for Adolescent oHCM
Bristol-Myers Squibb (NYSE: BMY) announced that the SCOUT‑HCM Phase III study of Camzyos (mavacamten) met its primary...
Summit Therapeutics Submits Ivonescimab BLA to FDA for EGFR‑Mutated NSCLC Post Third‑Gen TKI
Summit Therapeutics (NASDAQ: SMMT), the US partner of Akeso Inc. (HKG: 9926), announced the submission of...
Alphamab Oncology Submits Envafolimab for First‑Line Biliary Tract Cancer (BTC) as World’s First Subcutaneous PD‑L1
Alphamab Oncology (HKG: 9966) announced that China’s National Medical Products Administration (NMPA) has accepted its marketing...
Pfizer’s BRAFTOVI Trio Achieves 64 % Response Rate in BREAKWATER Cohort 3 for BRAF V600E Metastatic Colorectal Cancer
Pfizer Inc. (NYSE: PFE) announced that Cohort 3 of the pivotal Phase 3 BREAKWATER trial met its primary...
Insilico Medicine Doses First Patient in Phase IIa Study of AI‑Designed ISM5411 for Inflammatory Bowel Disease
Insilico Medicine (HKG: 3696) announced that the first patient has been dosed in the BETHESDA...
Lynk Pharmaceuticals Reports Positive Phase III Data for Zemprocitinib in Rheumatoid Arthritis – Best‑in‑Class JAK1 Inhibitor Shows 79 % ACR20 Response
Lynk Pharmaceuticals Co., Ltd. announced positive topline results from a pivotal Phase III trial of zemprocitinib...
Santen’s UPNEEQ Wins Japan Approval for Acquired Ptosis
Santen Pharmaceutical Co., Ltd. announced that UPNEEQ Mini 0.1% oxymetazoline solution (STN1013800) has been approved...
Hengrui’s Quadruple Prostate Cancer Combo Wins NMPA IND for Phase 2 Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that the National Medical Products...
Shanghai Pharma Receives NMPA Approval for Myasthenia Gravis Oral Solution
Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) announced that its subsidiary, Shanghai SPH Zhongxi Pharmaceutical...
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...
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...
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...
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...
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,...
Shanghai MicuRx’s Contezolid Patent Extended Through 2033, Securing Market Exclusivity
Shanghai MicuRx Pharmaceutical Co., Ltd (SHA: 688373) announced that the patent for its core product,...
Lilly’s Taltz-Zepbound Combo Meets Primary Endpoint in Psoriatic Arthritis
Eli Lilly (NYSE: LLY) announced positive topline results from the TOGETHER‑PsA open‑label Phase 3b trial evaluating...