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...
Drug
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...
Grand Pharmaceutical’s GPN01768 Accepted for Review by NMPA for Demodex Blepharitis Treatment
Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration...
Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has...
Abbisko Therapeutics Receives NMPA Approval for Irpagratinib Regulatory Study
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval...
Vocabria Receives Positive CHMP Opinion for HIV Treatment in Adolescents
GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by...
GSK’s Jemperli Receives Positive CHMP Opinion for Endometrial Cancer Indication Extension
The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European...
GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation...
CanSino Biologics’ DTcP Vaccine for Infants and Young Children Accepted by NMPA for Review
China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products...
EMA Grants PRIME Designation to Hansoh Pharmaceutical’s HS-20093 in Collaboration with GSK
The European Medicines Agency (EMA) has conferred Priority Medicines (PRIME) designation to HS-20093 (GSK5764227), a...
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...
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...