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FDA Roundup
FDA Roundup: October 15, 2024
FDA Roundup: October 11, 2024
The FDA approved a new drug for routine prophylaxis to prevent or reduce bleeding episodes in certain patients with hemophilia A or B, both without inhibitors.
DOJ enters a consent decree of permanent injunction against Rizo Lopez Foods Inc. prohibiting the company from manufacturing and selling certain food products.
FDA granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test
FDA Roundup: October 4, 2024
FDA Roundup: October 1, 2024
FDA Reorganization Go into Effect
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
FDA approved Aqneursa (levacetylleucine) for the treatment of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg.
FDA Roundup: September 24, 2024
FDA Roundup: September 20, 2024
FDA approves FluMist for self- or caregiver-administration. FluMist is approved for use in individuals 2 through 49 years of age for the prevention of influenza
The FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC).
FDA Roundup: September 17, 2024
The FDA issued a draft guidance that, when finalized, will provide sponsors with recommendations on multiregional clinical trials conducted for drugs intended t
FDA Roundup: September 13, 2024
The FDA authorized the first over-the-counter hearing aid software device intended to be used with compatible versions of the Apple AirPods Pro headphones.