Blog
RSS FeedPosted by Michael Wonder on 04 Mar 2019
Senators tell FDA to speed up approvals of generic insulin
1 March 2019 - A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy ...
Posted by Michael Wonder on 07 Feb 2019
Incyte announces U.S. FDA has extended the review period for ruxolitinib (Jakafi) in acute graft-versus-host disease
7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines
30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...
Posted by Michael Wonder on 22 Jan 2019
Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies
22 January 2019 - It's not accepting new applications or fees during the shutdown. ...
Posted by Michael Wonder on 22 Jan 2019
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...
Posted by Michael Wonder on 17 Jan 2019
FDA review of Aimmune drug put on hold due to government shutdown
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...
Posted by Michael Wonder on 16 Jan 2019
The FDA has five weeks till money runs out for approving new drugs
16 January 2019 - The US FDA has roughly five weeks of funding left to review new drug applications during ...
Posted by Michael Wonder on 15 Jan 2019
If the shutdown drags on at FDA, it will put anticipated new treatments in jeopardy
14 January 2019 - The government shutdown could soon jeopardise highly anticipated new drugs from Janssen, Sanofi, and Novartis for ...
Posted by Michael Wonder on 15 Jan 2019
How a 'regulatory dead zone' may be holding up copycat insulin
14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...
Posted by Michael Wonder on 21 Dec 2018
Merck provides update on Keytruda (pembrolizumab) supplemental biologics license application for KEYNOTE-042 trial
20 December 2018 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics license ...
Posted by Michael Wonder on 13 Dec 2018
A method for approximating future entry of generic drugs
13 December 2018 - The paper by Beall and colleagues relates to the development and testing of a method for approximating ...
Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted. ...
Posted by Michael Wonder on 19 Nov 2018
Gottlieb pushes for funding to speed gene therapy reviews
16 November 2018 - The FDA is working to increase its investment in reviewing gene therapy products, Commissioner Scott Gottlieb ...
Posted by Michael Wonder on 09 Nov 2018
Statement from FDA Commissioner on new efforts to strengthen FDA’s expanded access program
8 November 2018 - Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for ...
Posted by Michael Wonder on 09 Oct 2018
Statement from FDA Commissioner on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
9 October 2018 - As part of the U.S. FDA’s efforts to promote drug competition and patient access, we’ve advanced ...