New Drug Application (NDA)

Acerta Pharma: US FDA accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib inhibitor

CAMBRIDGE, 07-Aug-2017 — /EuropaWire/ — AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the…

7 years ago

GlaxoSmithKline submitted NDA to US FDA for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler

London, UK, 23-10-2013 — /EuropaWire/ — GlaxoSmithKline plc (LSE:GSK) today announced the submission of a New Drug Application (NDA) in the US…

11 years ago

GSK and Pfizer owned ViiV Healthcare announced US regulatory submission for STR combining dolutegravir with abacavir and lamivudine for people living with HIV

London, UK, 23-10-2013 — /EuropaWire/ — ViiV Healthcare today announced the submission of a regulatory application in the United States for its…

11 years ago