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...
Lōkahi Therapeutics, a subsidiary of Glucotrack, Inc., announced that The University of Alabama’s Culverhouse College of Business will continue it...
IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, announced...
XORTX Therapeutics Inc. (“XORTX” or the “Company”), a late-stage clinical pharmaceutical company focused on developing innov...
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved ...
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