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 ...
Altruist Biologics, a world-class contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics (1801.HK), a...
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...
XORTX Therapeutics Inc. (“XORTX” or the “Company”), a late-stage clinical pharmaceutical company focused on developing innov...
Flow Neuroscience announced that FL-100 is now available by prescription across the United States, introducing the first FDA-approved at-home transc...
Ingelheim, Germany - Boehringer Ingelheim announced the launch of PED Essentials, a comprehensive e-learning hub designed to help patient organizations g...
MaaT Pharma was informed of a negative trend during the Committee for Medicinal Products for Human Use (CHMP)’s Oral Explanation meeting which ...
Elixir Medical (Milpitas, Calif., and Tokyo) announced that its DynamX® Sirolimus-Eluting Coronary Bioadaptor System for the treatment of cor...
Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval...
Omniscient announced 510(k) clearance from the U.S. Food and Drug Administration for a new workflow within the Quicktome® platform: Quicktome Deep Br...
If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated diseas...
FDA sets Prescription Drug User Fee Act (PDUFA) date of March 10, 2027 Positions lonvo-z to be the world’s first in vivo CRISPR-based therapy an...
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