Two FDA advisory committees vote in a joint meeting to recommend approval of Mallinckrodt subsidiary SpecGxs investigative abuse-deterrent formulation...
PharmaCyte Biotech completes an FDA-required formal report on safety studies using a pig model that were undertaken before getting the agency to sign ...
FDA releases three International Medical Device Regulators Forum documents covering standards development, essential principles, and definitions.
FDA cautions healthcare professionals about the risks of using non-FDA approved pain medicines in implanted pumps.
Eli Lilly files an NDA for lasmiditan for the acute treatment of migraine and plans supplemental BLA for cluster headaches.
A California state appeals court says a lower court must consider new scientific evidence raised by plaintiffs who claim that three drug companies fai...
Ultragenyx Pharmaceutical completes a pre-NDA meeting and plans to submit an NDA for UX007 for treating patients with long-chain fatty acid oxidation ...
FDA releases an FDA-483 with eight observations from a recent inspection at a Dr. Reddys manufacturing facility in India.