Baxter Healthcare recalls its PrisMax System Version 2, a high permeability hemodialysis device, due to a software design error.
An FDA inspection of Philips Respironics results in a 29-page Form FDA-483 based on a Class 1 recall follow-up involving its continuous and non-contin...
The Biden Administration chooses former FDA head Robert Califf as its FDA commissioner nominee.
Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating a blindness causing conditi...
A Journal of Clinical Pharmacology study finds that FDA has less oversight of overseas clinical trials that are used to form the basis of approval for...
FDA approves a PharmaEssentia BLA for Besremi injection to treat adults with polycythemia vera, a blood disease associated with red blood cell overpro...
Novavax requests a meeting with FDA in advance of filing for approval of its Covid-19 vaccine.
FDA grants PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer.