Blog
RSS FeedPosted by Michael Wonder on 29 Mar 2020
Pharma’s future blockbusters laid up with coronavirus
27 March 2020 - Normally a haven during downturns, pharmaceuticals will see forthcoming products delayed as pandemic disrupts or delays clinical ...
Posted by Michael Wonder on 25 Mar 2020
Coronavirus drugs, vaccine are many months away, health experts say
24 March 2020 - Public- and private-sector medical officials cautioned that further study is needed to assess possible treatments pushed by ...
Posted by Michael Wonder on 12 Mar 2020
Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation
12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 05 Mar 2020
Trevena announces FDA has set PDUFA date of 7 August 2020 for oliceridine
5 March 2020 - FDA considers NDA resubmission a complete Class 2 response. ...
Posted by Michael Wonder on 05 Mar 2020
FDA track: PDUFA Performance
5 March 2020 - The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User ...
Posted by Michael Wonder on 27 Feb 2020
Zogenix announces FDA extension of review period for Fintepla in Dravet syndrome
27 February 2020 - Zogenix today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted 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 ...