Blog
RSS FeedPosted by Michael Wonder on 26 May 2018
The risks and benefits of expedited drug reviews
23 May 2018 - The US FDA oversees several programs that expedite approval of certain drugs that treat serious conditions ...
Posted by Michael Wonder on 23 May 2018
Gene therapies that could transform diseases get easier FDA path
23 May 2018 - Haemophilia treatments could be first under proposed method. ...
Posted by Michael Wonder on 17 May 2018
Statement from FDA Commissioner on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
17 May 2018 - No patients should be priced out of medicines they need to support their health. ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 10 May 2018
Games and greed delay the market entry of money-saving biosimilars
9 May 2018 - Generic medicines have saved Americans $1.67 trillion in the last decade. ...
Posted by Michael Wonder on 08 May 2018
Precision medicines have faster approvals based on fewer and smaller trials than other medicines
7 May 2018 - Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 03 May 2018
Migraine drug delay would compound Teva's troubles
2 May 2018 - Teva Pharmaceutical Industries is counting on its new migraine treatment to haul it out of the ...
Posted by Michael Wonder on 27 Apr 2018
The breakthrough therapy designation for promising cancer drugs is good for patients
27 April 2018 - One exciting component of the FDA Safety and Innovation Act was the creation of the breakthrough ...
Posted by Michael Wonder on 25 Apr 2018
Efficacy, safety, and regulatory approval of FDA–designated breakthrough and non-breakthrough cancer medicines
24 April 2018 - The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. ...
Posted by Michael Wonder on 18 Apr 2018
FDA official insists U.S. is catching up to Europe on biosimilar regulations, approvals
17 April 2018 - The FDA lags behind its European counterpart when it comes to approving biosimilars — but a ...
Posted by Michael Wonder on 05 Mar 2018
Accelerated approval in oncology: FDA touts successes, responds to criticism
5 March 2018 - A majority of oncology treatments granted accelerated approval over the last 25 years have gone on ...
Posted by Michael Wonder on 01 Mar 2018
Allergan announces FDA has extended the ulipristal acetate NDA review period to August 2018
1 March 2018 - Allergan today announced that it was notified by the U.S. FDA that the review of the new ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 31 Jan 2018
New drugs, but slow access — here's how to speed breakthroughs to patients
30 January 2018 - The U.S. FDA approved 46 novel drugs in 2017, a 21-year high. However, it could take ...