21 June 2019 - Earlier this month, the FDA announced the creation of Project Facilitate. ...
3 June 2019 - The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision. ...
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new ...
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...
1 March 2019 - A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy ...
7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...
22 January 2019 - It's not accepting new applications or fees during the shutdown. ...
18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...
16 January 2019 - The US FDA has roughly five weeks of funding left to review new drug applications during ...
14 January 2019 - The government shutdown could soon jeopardise highly anticipated new drugs from Janssen, Sanofi, and Novartis for ...
14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...