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RSS FeedPosted by Michael Wonder on 04 Jan 2017
A review of CDER’s novel drug approvals for 2016
4 January 2017 - This past year was another successful year for the new drugs program in FDA’s Center for Drug ...
Posted by Michael Wonder on 04 Jan 2017
U.S. FDA approves supplemental new drug applications to include landmark data in product labels for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets
4 January 2017 - The U.S. FDA approved supplemental new drug applications for three type 2 diabetes medicines within the empagliflozin ...
Posted by Michael Wonder on 04 Jan 2017
FDA accepts for filing supplemental new drug application for Lilletta (levonorgestrel-releasing intrauterine system)
4 January 2017 - Application seeks to extend duration of use up to 4 years. ...
Posted by Michael Wonder on 04 Jan 2017
Regorafenib granted priority review in the U.S. for second-line treatment of liver cancer
4 January 2017 - Bayer today announced that the U.S. FDA has granted priority review designation to the supplemental new drug ...
Posted by Michael Wonder on 04 Jan 2017
Drop in FDA approvals (and new administration) rekindles fears for the future of pharma
3 December 2016 - 2016 was a bummer! After years of rising FDA approvals that swelled to an all-time high of ...
Posted by Michael Wonder on 04 Jan 2017
Donald Trump could lower the bar for FDA drug approvals, but payers will limit access
3 January 2017 - They were hailed as drugs that could change the treatment of heart disease by lowering harmful LDL-cholesterol ...
Posted by Michael Wonder on 03 Jan 2017
Two key FDA decisions to watch out for in January 2017
2 January 2017 - The drug development process is often lengthy and time-consuming and requires the utilisation of a lot ...
Posted by Michael Wonder on 02 Jan 2017
New drug approvals fall to six-year low in 2016
2 January 2017 - Last year turned out to be a disappointing one for new drug approvals with the U.S. ...
Posted by Michael Wonder on 31 Dec 2016
Costly drug for fatal muscular disease wins FDA approval
30 December 2016 - The FDA has approved the first drug to treat patients with spinal muscular atrophy, a savage ...
Posted by Michael Wonder on 31 Dec 2016
The FDA’s rigged drug committees
30 December 2016 - A case study in how the agency gets the advice it wants to hear. ...
Posted by Michael Wonder on 30 Dec 2016
FDA completes guidance on the development of biosimilars
29 December 2016 - Drug makers received guidance from the FDA on 28 December on the development of biosimilar medicines. ...
Posted by Michael Wonder on 30 Dec 2016
Assessment of overall survival, quality of life, and safety benefits associated with new cancer medicines
29 December 2016 - What are the overall survival, quality of life, and safety benefits of recently licensed cancer medicines? ...
Posted by Michael Wonder on 30 Dec 2016
The head of the FDA defends the importance of drug effectiveness
29 December 2016 - First things first: FDA Robert Califf says that he has not had any contact with the ...
Posted by Michael Wonder on 30 Dec 2016
Coverage denial for therapy unconscionable
29 December 2016 - In regard to your 23 December Editorial “The FDA Empire Strikes Back”. ...
Posted by Michael Wonder on 30 Dec 2016
Cempra receives complete response letter from FDA for solithromycin NDAs
29 December 2016 - Cempra Pharmaceuticals today announced that the company has received a complete response letter from the U.S. ...