FDA releases the forms FDA-483 with multiple observations from inspections at Granules India Limited and Gland Pharma, both drug manufacturers in Tela...
Joint comments from three major drug companies about pediatric inflammatory bowel disease drug development question why FDA does not allow broader use...
Sens. Rubio and King push FDA to quickly finish implementing the Advanced Manufacturing Technologies Designation Program so industry knows what to exp...
The Institute for Clinical and Economic Review asks FDA to reconsider the implications of its stated goal in a draft guidance on clinical trial divers...
FDA approves an additional indication for Mercks Keytruda with chemotherapy to treat unresectable advanced or metastatic malignant pleural mesotheliom...
Congresswoman Nanette Barragn (D-CA) reintroduces the Prompt Approval of Safe Generic Drugs Act, legislation that would remove hurdles in the ANDA app...
FDA tells Applied Therapeutics its govorestat is on track for the 11/28 PDUFA action date and will not need to go before an advisory committee.
Smiths Medical recalls (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect.
