European CHMP Supports Conditional Approval of MSD’s Welireg for VHL Disease and RCC
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee...
Drug
EMA’s CHMP Recommends Approval of Bayer’s Acoramidis for ATTR-CM Treatment
Bayer’s (ETR: BAYN) acoramidis has received a positive recommendation from the Committee for Medicinal Products...
Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted...
ARS Pharmaceuticals’ Neffy Receives Market Filings in Asia-Pacific Region
US-based ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has announced that market filings for its intranasal epinephrine...
Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it...
Accropeutics Gets FDA Green Light for Phase II UC Study of RIPK2 Inhibitor AC-101
Accropeutics Inc., a clinical-stage biotechnology company with operations in New York, US, and Suzhou, China,...
EMA’s CHMP Supports Approval of Eli Lilly’s Omvoh (Mirikizumab) for Crohn’s Disease
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently...
Wepon Medical’s WP107 for Myasthenia Gravis Accepted for FDA Review
Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced that the US Food and...
Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Lupus Nephritis Clinical Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has obtained approval from...
Grand Pharmaceutical’s STC3141 Sepsis Therapy Completes Phase II Patient Enrollment
China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the completion of patient enrollment...
Innovent Biologics Initiates Phase I Trial for IBI3009 in Small Cell Lung Cancer and Neuroendocrine Tumors
On December 13, 2024, Innovent Biologics, Inc. (HKG: 1801) registered a Phase I clinical trial...
Huahai Pharmaceutical’s Adalimumab Biosimilar Accepted by China’s CDE for Review
On December 14th, the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE)...
Insilico Medicine Receives $10 Million Milestone Payment for XL309 Clinical Progress
Chengdu-based, generative artificial intelligence (AI)-driven clinical stage biotech company, Insilico Medicine, has announced the receipt...
Ascendis Pharma’s TransCon hGH sBLA for Adult GHD Accepted by FDA
Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) has announced that the US Food and Drug Administration...
Novo Nordisk’s Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication
Danish pharmaceutical leader Novo Nordisk (NYSE: NVO) has announced that the European Medicines Agency’s (EMA)...
Bayer AG Initiates Phase I Study Combining BAY3498264 with Sotorasib for KRAS-Mutated Tumors
Germany-based pharmaceutical giant Bayer AG (ETR: BAYN) has announced the initiation of a Phase I...
CureGene Pharmaceutical Gets NMPA Approval for Antiplatelet Drug CG-0255
Shanghai-based CureGene Pharmaceutical has announced receiving clinical trial approval from China’s National Medical Products Administration...
Pfizer’s Ibrance Demonstrates Significant PFS Improvement in Phase III PATINA Trial
US pharmaceutical major Pfizer Inc. (NYSE: PFE) and Alliance Foundation Trials, LLC (AFT) have announced...
Gan & Lee Pharmaceuticals Gets FDA Approval for GZR18 Obesity/Overweight Phase II Study
China-based Gan & Lee Pharmaceuticals (SHA: 603087) has announced that it has received approval from...
HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib),...