FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasi...
FDA releases the form FDA-483 with nine observations from an inspection at Frances Fareva Amboise drug manufacturing facility.
Three Ropes & Gray attorneys outline FDAs new plausible mechanism pathway for approving personalized therapies and discuss questions that remain about...
Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability.
Novo Nordisk files a supplemental NDA seeking approval for a higher-dose version of weight-loss drug Wegovy (semaglutide).
A law journal article, discussed in Regulatory Review, proposes a framework courts could use to consider state challenges to federal preemption of dru...
The Department of Justice says a Massachusetts federal judge sentenced three former Magellan Diagnostics executives for hiding a malfunction in the co...
FDA warns Chinas Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices.
