Blog
RSS FeedPosted by Michael Wonder on 03 Jun 2020
Hahn: FDA will make some changes amid COVID-19 permanent
1 June 2020 - The US FDA will look to permanently implement some of the processes and policies adopted in ...
Posted by Michael Wonder on 02 Jun 2020
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...
Posted by Michael Wonder on 24 May 2020
U.S. is ahead of China in vaccine race, former FDA chief says
24 May 2020 - Data on Chinese vaccines in clinical development “didn’t look overwhelmingly strong,” Scott Gottlieb said. ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...
Posted by Michael Wonder on 12 May 2020
COVID-19 update: FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19
11 May 2020 - Today, the U.S. FDA took important actions to help accelerate the development of prevention and treatment options ...
Posted by Michael Wonder on 06 May 2020
Bristol Myers Squibb provides update on biologics license application for lisocabtagene maraleucel
6 May 2020 - Bristol Myers Squibb today announced that the U.S. FDA has extended the action date by three ...
Posted by Michael Wonder on 27 Apr 2020
Vaccine could potentially be available later this year, coalition says
27 April 2020 - Group head hopes to deliver shots sooner than 12-18 months. ...
Posted by Michael Wonder on 08 Apr 2020
Genentech provides regulatory update on risdiplam for the treatment of spinal muscular atrophy
7 April 2020 - U.S. FDA extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2. ...
Posted 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. ...