Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new dr...
Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announced that it was notified by its licensing partner, Changchun GeneScience Pharmaceutical Co., Ltd. (...
Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) announced that the U.S. Food and Drug Admin...
FDA approval is based on results from the landmark Phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plu...
The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA® (finerenone) in adult...
Solengepras 150 mg achieved a statistically significant reduction in daily OFF time, with benefit seen at Week 2 Statistically significant improvements ...
Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced tha...
Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in dela...
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced positive topline results from its pivotal Phase III study of HETLIOZ® (tasimelteon) 20 mg in a...
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that U.S. laboratories now have access to the complete QIAstat-Dx bloodstream infection p...
The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as M...
If approved, Joenja would be available to eligible patients aged 4 years and older with APDS who weigh 13 kg or more Decision follows recent approval ...
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment...
Andelyn Biosciences (“Andelyn”), a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (&ldqu...
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