Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2020
Coronavirus Treatment Acceleration Program
1 April 2020 - FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program. ...
Posted by Michael Wonder on 01 Apr 2020
COVID-19 update: FDA continues to accelerate development of novel therapies for COVID-19
31 March 2020 - As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the ...
Posted by Michael Wonder on 31 Mar 2020
Developing COVID-19 vaccines at pandemic speed
30 March 2020 - Rapid publication of a perspective co-authored by former head of Australian Department of Health. ...
Posted 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. ...