Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products...
Drug
Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical...
Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc....
TAHO Pharma’s TAH3311 Oral Film Shows Bioequivalence to Eliquis in Study
Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral...
Sanofi’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has...
Biokin Pharmaceutical’s BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer
China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from...
Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its...
Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received...
InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL
Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from...
Hengrui Pharma’s HR19034 Eye Drops for Myopia Delay Accepted by NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its market filing for HR19034 eye...
Gan & Lee Pharmaceuticals Doses First Patient in GZR4 Phase III Study for Diabetes
China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed...
Zelgen Biopharmaceuticals’ ZG005 Bispecific Antibody Receives NMPA Approval for Biliary Tract Cancer Trials
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial...
Bristol-Myers Squibb Releases Five-Year Data on Sotyktu’s Long-Term Efficacy and Safety
In a recent announcement, US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) unveiled the latest...
Wanbangde New Building Materials’ Mecobalamin Earns FDA Orphan Drug Designation for ALS
China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) announced that its mecobalamin product has...
Biokin Pharmaceutical Registers Phase III Study for BL-B01D1 in EGFR Mutant NSCLC
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has registered a Phase III study on chinadrugtrials.org.cn...
AccurEdit’s ART002 Becomes First In Vivo Gene Editing Product to Reduce LDL-C in Humans
Suzhou-based gene editing specialist AccurEdit Therapeutics announced that its in vivo gene editing product, ART002,...
Huadong Medicine’s HDM1005 Shows Positive Results in Phase Ia/Ib Study
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced positive results from the Phase Ia/Ib study...
Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the...
Kexing Biopharm’s GB05 Receives FDA Approval for Pediatric RSV Infections
China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced that it has received clinical trial approval...
Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar...