The DC federal court says FDA should reconsider its exclusivity decision for Indiviors Sublocade that blocked Braeburns Brixadi from approval.
FDA warns High Chemical about CGMP deviations in its production of active pharmaceutical ingredients.
FDA issues a Warning Letter to Curaleaf (Wakefield, MA) for illegally selling unapproved products containing cannabidiol online with unsubstantiated p...
Federal Register notice: FDA makes available a final guidance entitled Postmarketing Safety Reporting for Combination Products Guidance for Industry a...
Medtronic files a PMA for non-adjunctive labeling for its Guardian Sensor 3, which is part of the MiniMed 670G insulin delivery system.
Restore Public Trust says the drug industry is setting new records for lobbying spending in an effort to influence the Trump administration and Congre...
FDA releases its latest batch of Warning Letters that includes High Chemical, Indoco Remedies and Stratus BioSystems.
FDA says Bayer is recalling two lots of Kogenate FS because some vials contained its Jivi antihemophilic factor rather than Kogenate.