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...
Drug
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...
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...