Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry as a diagnosis of a...
A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.
Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.
CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring improved during the third...
AstraZeneca and Ionis Pharmaceuticals say that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients with transthyretin-me...
Two former FDAers petition the agency to appoint an advisory committee to consider whether anticholinergic drugs are associated with an increased risk...
FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.
FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing fac...
