FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with advanced cervical cancer that is prog...
Stakeholders tell FDA ways it could improve a draft guidance on the least burdensome concept for medical device regulation.
FDA places on clinical hold an Advaxis IND for a Phase 1/2 combination study of axalimogene filolisbac with AstraZenecas Imfinzi (durvalumab) for trea...
FDA warns Laser Dental Innovations about Quality System violations in its manufacturing of dental handpieces and laser fiber optic surgical devices.
Rep. Frank Pallone introduces legislation to strength FDA authority to combat illegal opioid importation.
FDA warns Koreas Dexcowin Co. about multiple Quality System violations in its manufacturing of portable dental diagnostic X-ray devices.
FDA issues an FDA-483 with six observations from an inspection at Biocon, a Malaysian sterile drug producer.
FDA releases its latest batch of Warning Letters that includes Dexcowin Co., Laser Dental Innovations and Quali-Controle & Quali-Controle.