Blog
RSS FeedPosted by Michael Wonder on 19 Apr 2017
Egalet announces U.S. FDA acceptance of file for prior approval supplement for Oxaydo (oxycodone hydrochloride) tablets 10 mg and 15 mg dosage strengths
18 April 2017 - FDA goal date is 17 June 2017. ...
Posted by Michael Wonder on 18 Apr 2017
FDA grants Roche’s Tecentriq (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer
18 April 2017 - First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable ...
Posted by Michael Wonder on 18 Apr 2017
FDA approves Genentech’s Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States
17 April 2017 - Granted priority review designation by the FDA based on analysis of results from a National Institutes of ...
Posted by Michael Wonder on 17 Apr 2017
Enzyvant receives FDA breakthrough therapy designation and regenerative medicine advanced therapy designation for investigational therapy RVT-802
17 April 2017 - Enzyvant anticipates potential BLA filing in the first half of 2018. ...
Posted by Michael Wonder on 17 Apr 2017
AMAG submits supplemental new drug application to FDA for Makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use
17 April 2017 - FDA decision anticipated on supplemental new drug application filing in the fourth quarter 2017. ...
Posted by Michael Wonder on 14 Apr 2017
U.S. FDA issues complete response letter for baricitinib
14 April 2017 - Eli Lilly and Incyte Corporation announced today that the U.S. FDA has issued a complete response ...
Posted by Michael Wonder on 14 Apr 2017
Fast start for FDA drug approvals in 2017
12 April 2017 - The US FDA is poised to make a comeback from the relatively low number of new ...
Posted by Michael Wonder on 14 Apr 2017
Relmada announces FDA fast track designation for d-methadone for adjunctive treatment of major depressive disorder
13 April 2017 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation for d-Methadone (REL-1017, dextromethadone), ...
Posted by Michael Wonder on 11 Apr 2017
FDA approves first drug to treat tardive dyskinesia
11 April 2017 - The U.S. FDA today approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the ...
Posted by Michael Wonder on 07 Apr 2017
Innocrin Pharmaceuticals granted fast track designation by FDA for seviteronel treatment of women with triple-negative breast cancer and women or men with estrogen receptor-positive breast cancer
6 April 2017 - Innocrin has announced that the FDA granted a second fast track designation for seviteronel (VT-464). ...
Posted by Michael Wonder on 07 Apr 2017
Merck receives complete response letter from the U.S. FDA for TECOS study with sitagliptin
7 April 2017 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental new ...
Posted by Michael Wonder on 07 Apr 2017
FDA approves two hepatitis C drugs for paediatric patients
7 April 2017 - The U.S. FDA today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to ...
Posted by Michael Wonder on 06 Apr 2017
Regeneron announces evinacumab has received FDA breakthrough therapy designation for homozygous familial hypercholesterolaemia
6 April 2017 - Regeneron Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation status to evinacumab ...
Posted by Michael Wonder on 06 Apr 2017
F.D.A. nominee deflects criticism about ties to drug makers at hearing
5 April 2017 - Dr. Scott Gottlieb, President Trump’s nominee to lead the FDA, told Congress on Wednesday that he ...
Posted by Michael Wonder on 06 Apr 2017
Regulatory review of new therapeutic agents — FDA versus EMA (2011–2015)
6 April 2017 - The FDA faces continual pressure to accelerate the regulatory review and approval of new medicines. ...