FDA approves Johnson & Johnsons Icotyde as the first and only targeted oral peptide to treat plaque psoriasis in adults and some pediatric patients.
Public health experts call for sweeping reforms to improve FDAs transparency, arguing that longstanding gaps in disclosure persist despite recent prog...
FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater...
FDA issues an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet.
FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.
FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare...
Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures ...
