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RSS FeedPosted by Michael Wonder on 05 Jan 2017
Fibrocell announces FDA fast track designation of FCX-007 for treatment of recessive dystrophic epidermolysis bullosa
5 January 2017 - Fibrocell Science today announced that the U. S. FDA has granted fast track designation to FCX-007, the ...
Posted by Michael Wonder on 05 Jan 2017
New FDA drug approvals: breaking down the numbers
4 January 2017 - If a decline in FDA approvals of new pharmaceuticals is a bad sign for the industry, ...
Posted by Michael Wonder on 05 Jan 2017
New “21st Century Cures” legislation: speed and ease versus science
5 January 2017 - The 21st Century Cures Act was signed into law in December 2016. Praised by its advocates as ...
Posted by Michael Wonder on 05 Jan 2017
Neurelis intra-nasal diazepam treatment for epilepsy granted fast track designation by FDA
4 January 2017 - Neurelis today announced that the US FDA has designated NRL-1 (intranasal diazepam) as a fast track development ...
Posted by Michael Wonder on 05 Jan 2017
FDA grants fast track designation to Enanta's FXR agonist candidate EDP-305 for the treatment of NASH with liver fibrosis
4 January 2017 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted Enanta’s drug candidate EDP-305, an FXR agonist, ...
Posted 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
The changing face of clinical trials: the large pharmaceutical company perspective
4 January 2017 - Large pharmaceutical companies conduct clinical trials to evaluate efficacy and identify safety issues for candidate drugs as ...
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
Ebola vaccine fast-tracked after proven 100 percent effective in trials
1 January 2017 - Scientists battling the deadly Ebola virus are poised for a breakthrough in the new year after ...
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. ...