Blog
RSS FeedPosted by Michael Wonder on 20 Sep 2018
Generics would hit the market faster under Senate bill, saving more than 3 billion dollars, says CBO
19 September 2018 - Lower-price drugs would hit the market faster under a bipartisan bill awaiting a vote in the ...
Posted by Michael Wonder on 14 Sep 2018
Acorda announces FDA extends Inbrija NDA review period
13 September 2018 - New PDUFA date of 5 January 2019. ...
Posted by Michael Wonder on 16 Jul 2018
U.S. FDA extends review timeline for Invokana (canagliflozin) supplemental new drug application
13 July 2018 - The application seeks a new indication for Invokana to reduce the risk of major adverse cardiovascular ...
Posted by Michael Wonder on 04 Jun 2018
FDA wants to shorten new drug monopolies to cut costs
4 June 2018 - In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb ...
Posted by Michael Wonder on 03 Jun 2018
FDA chief outlines new ways to speed cancer drug approvals
2 June 2018 - The U.S. FDA is taking steps to streamline the approval process for cancer drugs, reviewing clinical ...
Posted by Michael Wonder on 30 May 2018
Accelerated approval of medicines: fit for purpose?
30 May 2018 - The uptake of a new medicine represents a balance between benefit–risk assessment and value considerations. In the ...
Posted 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 ...