Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 Sep 2018
Generics would hit the market faster under Senate bill, saving more than 3 billion dollars, says CBO
19 September 2018 - Lower-price drugs would hit the market faster under a bipartisan bill awaiting a vote in the ...
Posted by Michael Wonder on 14 Sep 2018
Acorda announces FDA extends Inbrija NDA review period
13 September 2018 - New PDUFA date of 5 January 2019. ...
Posted by Michael Wonder on 16 Jul 2018
U.S. FDA extends review timeline for Invokana (canagliflozin) supplemental new drug application
13 July 2018 - The application seeks a new indication for Invokana to reduce the risk of major adverse cardiovascular ...
Posted by Michael Wonder on 04 Jun 2018
FDA wants to shorten new drug monopolies to cut costs
4 June 2018 - In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb ...