FDA accepts for priority review a Chiesi NDA for idebenone and its use in treating Leber hereditary optic neuropathy.
FDA posts a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests during a declared public ...
FDA grants accelerated approval to a Stealth Biotherapeutics NDA for Forzinity (elamipretide) injection for treating Barth syndrome.
FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic stress disorder in ad...
FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovorin calcium tablets ...
Rep. Frank Pallone Jr. (D-NJ) sharply criticizes Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of undermining vaccine access...
FDA approves Medtronics Altaviva implantable tibial neuromodulation device for treating urge urinary incontinence.
FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...
