FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical...
Drug
Janssen-Cilag Submits for IMBRUVICA Indication Extension in Untreated Mantle Cell Lymphoma
Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA...
Chengdu Kanghua Biological Receives NMPA Approval for Recombinant Norovirus Vaccine
Chengdu Kanghua Biological Products Co., Ltd, (SHE: 300841), a leading biopharmaceutical company based in China,...
Huadong Medicine’s HDM1005 Receives FDA Clearance for Heart Failure and Obesity Clinical Trial
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from...
Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1501 Combo in Bladder Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that...
Sino Biopharmaceutical’s Benmelstobart Meets Primary Endpoint in Phase III NSCLC Study
Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biopharmaceutical company, has announced positive results from...
UCB’s Minzasolmin Fails to Meet Endpoints in ORCHESTRA Study for Early Parkinson’s
Belgium-based biopharmaceutical company UCB (EBR: UCB) has announced the disappointing results of the ORCHESTRA proof-of-concept...
Everest Medicines’ Velsipity (Etrasimod) Receives First Prescription in Foshan under GBA Policy
Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced that its...
ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Amulirafusp Alfa in NMOSD
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced the commencement of...
Eli Lilly’s Kisunla Receives NMPA Approval for Early Alzheimer’s Disease Treatment
Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical corporation in the US, has announced...
BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s...
Evopoint Biosciences Submits Pre-NDA for Funobactam, Imipenem, and Cilastatin to NMPA
Suzhou-based Evopoint Biosciences Co., Ltd. has announced the submission of a Pre-NDA (New Drug Application)...
GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK)...
Sciwind Biosciences’ Ecnoglutide Accepted for Review by NMPA for Weight Management
Sciwind Biosciences Co., Ltd has received a significant boost as the National Medical Products Administration...
Everest Medicines’ Velsipity NDA for Ulcerative Colitis Accepted by China’s NMPA
China-based Everest Medicines (HKG: 1952) has announced that the National Medical Products Administration (NMPA) has...
AstraZeneca’s ALXN2350 Selected for CDE’s Rare Disease Drug Development Program
The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s...
MSD Halts Development of Vibostolimab and Favezelimab Due to Trial Setbacks
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed its decision to...
Vcanbio’s VUM02 Secures NMPA Approval and FDA ODD for Cirrhosis and aGvHD
China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced significant progress for...
Johnson & Johnson Submits sBLA to FDA for Simponi in Pediatric Ulcerative Colitis
US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a...
J&J’s SC Amivantamab Faces Complete Response Letter from FDA for NSCLC Treatment
Johnson & Johnson (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed...