Blog
RSS FeedPosted by Michael Wonder on 07 Feb 2020
Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour
6 February 2020 - PDUFA action date extended by three months to 14 May 2020. ...
Posted by Michael Wonder on 20 Jan 2020
FDA delays decision on Intercept's NASH drug by three months
20 January 2020 - Action date pushed back to 26 June. ...
Posted by Michael Wonder on 08 Jan 2020
FDA – 2019 in review
8 January 2020 - Analysis of NDA approval timelines for 2019. ...
Posted by Michael Wonder on 04 Jan 2020
FDA’s deadline problem?
3 January 2020 - Rush to meet end-of-year drug-approval deadlines leads to more adverse effects, new study shows. ...
Posted by Michael Wonder on 10 Dec 2019
Speeding access to new and innovative cancer treatments
8 December 2019 - An emerging measure for predicting cancer treatment outcomes could dramatically speed clinical trials and the approval of ...
Posted by Michael Wonder on 09 Dec 2019
FDA approving drugs at breakneck speed, raising alarm
7 December 2019 - Breakthrough products beating deadlines by weeks, even months. ...
Posted by Michael Wonder on 19 Oct 2019
Criticism won’t slow targeted cancer drug reviews: FDA official
18 October 2019 - FDA’s accelerated approval pathway has faced criticism it’s not really helping patients. ...
Posted by Michael Wonder on 14 Oct 2019
Flexion Therapeutics announces extended FDA review of supplemental new drug application for Zilretta
14 October 2019 - Flexion Therapeutics today announced that the U.S. FDA has informed the company it needs additional time ...
Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
Posted by Michael Wonder on 22 Jun 2019
Should the FDA speed up or slow down approval of new cancer drugs?
21 June 2019 - Earlier this month, the FDA announced the creation of Project Facilitate. ...
Posted by Michael Wonder on 04 Jun 2019
US FDA review for Scenesse extended by three months
3 June 2019 - The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision. ...
Posted by Michael Wonder on 04 Apr 2019
Daiichi Sankyo provides update on ongoing FDA review for quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...
Posted by Michael Wonder on 13 Mar 2019
Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...