The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...
VANCOUVER, BC / ACCESS Newswire / October 21, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug ...
These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote. Factors that may affect the bioequivalence of test ...
NEW HAVEN, Conn., Nov. 6, 2017 /PRNewswire/ -- (NYSE: BHVN) - Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven" or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc.
LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today ...
New Drug Application to be submitted in early 2026; target PDUFA in Q1 2027 Utility patent applications filed with potential exclusivity to 2044 PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)-- Harmony ...
WAYNE, Pa., June 25, 2015-- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain ...
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