Indias Panacea Biotec says it is working with FDA to close a recent inspection that had eight observations and an Official Action Indicated classifica...
FDA issues a safety alert to warn about potential clip lock malfunctions with Abbotts MitraClip Delivery Systems.
FDA approves a Revance Therapeutics BLA for injectable Daxxify (daxibotulinumtoxinA-lanm) for temporarily improving moderate-to-severe frown lines.
FDA issues a draft guidance intended to improve the consistency of labeling for nonprescription drugs.
In an unusual second advisory committee meeting in six months, panel members reverse their March vote and recommend approval for Amylyxs amyotrophic l...
FDA releases a Form FDA-483 with seven observations from an inspection at Koreas Hugel drug substance and drug product manufacturing facility.
FDA publishes a draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biologics.
Philips Respironics recalls 17 million masks used with bilevel positive airway pressure machines and continuous positive airway pressure machines due ...
