Blog
RSS FeedPosted by Michael Wonder on 13 Jun 2020
Antimicrobials benefited from expedited FDA programs more than other drugs
12 June 2020 - Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more ...
Posted by Michael Wonder on 11 Jun 2020
U.S. FDA Commissioner says agency seeks fast review of COVID-19 products
11 June 2020 - The U.S. FDA is seeking to review treatments and tests for COVID-19 “as fast as we can” ...
Posted by Michael Wonder on 03 Jun 2020
The FDA should not rush a COVID-19 vaccine
2 June 2020 - Vaccines are widely expected to offer the best way out of the COVID-19 pandemic. ...
Posted by Michael Wonder on 03 Jun 2020
Antimicrobial approvals are not bottlenecked by FDA
3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...
Posted 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. ...