Lykos Therapeutics Faces Setback as FDA Rejects Midomafetamine for PTSD Treatment
Lykos Therapeutics, a U.S.-based biotech firm, has expressed concern over the impact of the FDA’s...
Drug
Chugai Seeks Approval for Elevidys Gene Therapy in Japan, Targeting Duchenne Muscular Dystrophy
Chugai Pharmaceutical Co., Ltd. (TYO: 4519), a subsidiary of Roche, has submitted a product approval...
Staidson Launches Phase Ia Trial for STSP-0902 Injection in Oligoasthenozoospermia
Staidson (Beijing) Pharmaceutical Co., Ltd. (SHE: 300204) has announced that it has received approval from...
Jiangsu Hengrui Secures NMPA Approval for Clinical Trials of SHR-2106 in Primary Sjögren’s Syndrome
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial...
Vimgreen Pharma Launches Phase II Trial for A2AR Antagonist VG081821AC in Parkinson’s Disease
Zhejiang-based Vimgreen Pharma has announced the launch of a Phase II clinical trial for its...
Gilead Secures FDA Accelerated Approval for Livdelzi in Liver Disease Treatment
Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its...
Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the...
Shandong Buchang Pharmaceuticals Partners with Lancet for BC001 Licensing in Eurasia
Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858), based in China, has announced plans to enter...
Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced...
CStone to Manufacture Gavreto Locally Following NMPA Approval, Expanding Market Presence
CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has received approval from the National Medical...
Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers...
Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
Ascentage Pharma (HKG: 6855), based in China, has received approval from the National Medical Products...
Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and...
Novartis Intensifies Legal Action Against FDA Over Entresto Generic Approval
Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors...
Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant...
Hengrui Pharmaceuticals Launches Phase II Trial for SHR7280 to Treat Uterine Fibroids
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has received approval...
GSK Initiates Phase III Study for RSV Vaccine in China Following U.S. Approval
GSK (NYSE: GSK), the UK-based pharmaceutical giant, has registered a Phase III bridging study for...
Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National...
Pfizer’s Hemophilia Treatment Marstacimab Accepted for Review in China
The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing...
Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing...