Editor's note: This article was updated on 11 January 2024 to correct a typo. The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) issued a report on the 55 novel ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, ...
GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...
The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire from the agency. The seven-year FDA veteran communicated the decision in an ...
The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the helm amid a period of senior leadership instability at the agency. Pazdur, ...
Add Yahoo as a preferred source to see more of our stories on Google. CDER director Richard Padzur has handed in his retirement papers after under a month in his new position at the FDA. Image credit: ...
The FDA selected Gerald Dal Pan as director of the Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). Dal Pan will report directly to the head of CDER, elevating the stature ...
WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...