FDA issues an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing de...
Teva sues FDA to force it to transition the NDA for Copaxone to a BLA as required under the Biologics Price Competition and Innovation Act.
FDA accepts an Innocoll Holdings NDA resubmission for post-surgical pain product Xaracoll (bupivacaine hydrochloride collagen-matrix implants).
FDA approves Xellia Pharmaceuticals Cleveland, OH manufacturing site to make anti-infective drug products for the U.S. market.
FDA approves Bristol-Myers Squibbs Zeposia, a new oral treatment for relapsing multiple sclerosis.
FDA authorizes Pears Somryst prescription-only digital therapeutic intended to treat chronic insomnia in adults age 22 and older.
FDA says it does not regulate as medical devices many digital health solutions used by public health officials and the public to manage response to Co...