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...
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...
FDA grants priority review for Sanofi's dengue vaccine candidate Medical Dialogues Bureau4 Nov 2018 11:00 AM ISTThe vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European...
