FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating spinal muscular atrop...
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 extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted recently.
Roche reports positive Phase 3 data with its investigational breast cancer drug giredestrant.
FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies developing drugs targeting ...
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.
