Sunovion Pharma resubmits application to USFDA for sublingual Apomorphine to treat Parkinsons disease Farhat Nasim25 Dec 2019 9:15 AM ISTNew Delhi: Sunovion Pharmaceuticals Inc. (Sunovion) recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug...
Novartis wins USFDA approval for first PI3K inhibitor for breast cancer Farhat Nasim27 May 2019 6:10 PM ISTThe drug, alpelisib, to be marketed under the brand name Piqray, belongs to a class of drugs known as PI3K inhibitors and is the first of its kind to...
USFDA accepts Allergan license applications to expand Botox label Farhat Nasim11 March 2019 9:30 AM IST"The FDA's acceptance of Allergan's supplemental biologics license applications is a monumental milestone on our journey to bring new treatment...
Pfizer says USFDA accepts regulatory submissions for review of tafamidis Medical Dialogues Bureau16 Jan 2019 9:35 AM ISTPfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial...
