FDA issues an Emergency Use Authorization (EUA) for Modernas Covid-19 vaccine for use in individuals 18 years of age and older.
FDA posts a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsors about eligibility ...
FDA approves Myovant Sciences Orgovyx (relugolix) for treating adult patients with advanced prostate cancer.
FDA approves an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for adults who have above...
CDER Office of Compliance director Donald Ashley tells a Food and Drug Law Institute conference that FDA is continuing to explore using remote regulat...
Biogen agrees to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations as conduits to pay Me...
Federal Register notice: FDA makes available a final guidance entitled Controlled Correspondence Related to Generic Drug Development.
Federal Register notice: FDA makes available a draft guidance entitled Dry Eye: Developing Drugs for Treatment.