Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an effort to advance its...
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.
