[ Price : $8.95]
FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating s...[ Price : $8.95]
FDA posts a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests durin...[ Price : $8.95]
FDA grants accelerated approval to a Stealth Biotherapeutics NDA for Forzinity (elamipretide) injection for treating Barth syndrom...[ Price : $8.95]
FDA extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted r...[ Price : $8.95]
Roche reports positive Phase 3 data with its investigational breast cancer drug giredestrant.[ Price : $8.95]
FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies develop...[ Price : $8.95]
Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an e...[ Price : $8.95]
FDA accepts for priority review a Chiesi NDA for idebenone and its use in treating Leber hereditary optic neuropathy.