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 Oklahoma Supreme Court says a lower court erred in determining that J&J violated the states public nuisance law in the way it marketed prescriptio...
FDA grants Elevar Therapeutics an orphan drug designation for rivoceranib and its use for treating hepatocellular carcinoma.
FDA accepts for priority review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) 10 mg for reducing the risk of car...
FDA clears a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons in performing navigated tot...
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.