Nuvation Bio’s Taletrectinib NDA for ROS1+ NSCLC Receives FDA Priority Review
US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for...
Market approval filings
Sino Biopharmaceutical Ltd. Files for Benmelstobart and Anlotinib Combination Therapy in ASPS Treatment
China-based Sino Biopharmaceutical Ltd (HKG: 1177) is poised to make another indication approval filing with...
MSD’s Clesrovimab for Infant RSV Protection: FDA Accepts BLA for Review
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and 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)...
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...
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...
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...
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...
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...
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)...
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...
CSPC Pharmaceutical Group’s SYHX2011 for Metastatic Breast Cancer Accepted for NMPA Review
China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that the National Medical Products...
GSK’s Nucala Receives FDA Review for COPD Indication Based on MATINEE Study Data
UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration...
TJ Biopharma and Jumpcan Pharmaceutical Announce NMPA Review of Eftansomatropin Alfa BLA
Chinese partners TJ Biopharma and Jumpcan Pharmaceutical (SHA: 600566) have jointly announced that the National...
AstraZeneca’s Imfinzi Receives FDA Priority Review for Muscle-Invasive Bladder Cancer
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that the US Food and Drug...
Roche’s Columvi Supplemental sBLA Accepted by FDA for Relapsed DLBCL Treatment
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the US Food and Drug Administration...
Johnson & Johnson Submits sBLAs to FDA for Tremfya Indications in Pediatric Psoriasis and Arthritis
Global healthcare giant Johnson & Johnson (J&J; NYSE: JNJ) has announced the submission of two...
Humanwell Healthcare’s Recombinant Plasmid Hepatocyte Growth Factor Injection Accepted for NMPA Review
China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that the National Medical Products...
Shanghai Henlius Biotech’s HLX11 Biosimilar Accepted for Review by China’s CDE
Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced...