The DC federal court throws out Norwichs suit seeking to force FDA to find that Actavis has forfeited its exclusivity for a generic form of rifaximin ...
FDA commissioner Martin Makary says there are no current plans to restrict access to the abortion drug mifepristone.
Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the device experiences a sudden power loss.
Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff shortages resulting from ...
FDA approves an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
The Association for Clinical Oncology tells the new leaders of FDA, NIH, and CMS it looks forward to working with them on behalf of cancer research an...
Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antipsychotics for patien...
Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness information.
