[ Price : $8.95]
FDA accepts for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat...[ Price : $8.95]
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resec...[ Price : $8.95]
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating childre...[ Price : $8.95]
FDA releases the form FDA-483 with nine observations from an inspection at Frances Fareva Amboise drug manufacturing facility.[ Price : $8.95]
Three Ropes & Gray attorneys outline FDAs new plausible mechanism pathway for approving personalized therapies and discuss questio...[ Price : $8.95]
Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability.[ Price : $8.95]
Novo Nordisk files a supplemental NDA seeking approval for a higher-dose version of weight-loss drug Wegovy (semaglutide).[ Price : $8.95]
A law journal article, discussed in Regulatory Review, proposes a framework courts could use to consider state challenges to feder...