FDA says its monitoring of breast implants has detected some cases of squamous cell carcinoma and various lymphomas in the scar tissue around the impl...
FDA publishes an immediately effective guidance on emergency use authorizations for monkeypox diagnostic tests.
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FDA issues a draft guidance intended to improve the consistency of labeling for nonprescription drugs.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.
