AIM Vaccine’s Serum-Free Rabies Vaccine Accepted for Review by NMPA
China-based AIM Vaccine Co., Ltd (HKG: 6660) announced that its market filing for a serum-free...
Market approval filings
Henlius and Organon’s HLX11 Biosimilar Clears EMA Validation Hurdle
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines...
Huadong Medicine’s Semaglutide Injection Accepted for Review by China’s NMPA
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...
Otsuka Files FDA Application for Sibeprenlimab in IgAN Treatment
Japan-based Otsuka Pharmaceutical Co., Ltd. announced the filing of a Biologics License Application (BLA) with...
GSK’s Nucala Accepted for EMA Review for COPD Treatment
UK-based GSK plc’s (LON: GSK, NYSE: GSK) application for expanding the use of its anti-interleukin-15...
CStone Pharmaceuticals Files for EMA Approval of Sugemalimab for Unresectable Stage III NSCLC
China-based CStone Pharmaceuticals (HKG: 2616) has announced filing for another indication approval for its anti-programmed...
Arcutis Biotherapeutics’ Zoryve Cream Nears FDA Approval for Pediatric Atopic Dermatitis
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc....
Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction
German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for...
Simcere Pharmaceutical’s ADC189 NDA Accepted for Influenza Treatment
Simcere Pharmaceutical Group Limited (HKG: 2096) and AnDiConBio announced that the New Drug Application (NDA)...
Bio-Thera Solutions’ BAT2506 Biosimilar Accepted for Review by China’s NMPA
China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a...
Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for...
Fosun Pharmaceutical’s Foritinib Accepted for Review by China’s NMPA for NSCLC Treatment
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that the National...
Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and...
Huadong Medicine’s V30 Optical Radiofrequency Device Receives NMPA Review Approval
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...
GSK’s Depemokimab Accepted for FDA Review as Ultra-Long-Acting Biologic
GSK plc (LON: GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA)...
Tonghua Dongbao’s Tongboli Under GMP Inspection in Egypt
China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced that the on-site Good Manufacturing Practice (GMP) inspection...
Precigen’s RRP Therapy PRGN-2012 Gets FDA Review
US-based cell and gene therapy (CGT) specialist Precigen, Inc. (NASDAQ: PGEN) announced that the US...
Merck’s Keytruda sBLA for LA-HNSCC Accepted by FDA for Review
Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug...
Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for...
Boehringer Ingelheim’s Nerandomilast Receives NMPA Review for IPF Treatment
Boehringer Ingelheim announced that its investigational drug nerandomilast has been accepted for review by the...