Tag Archives: New Drug Application

FDA Accepts AstraZeneca’s NDA for Capivasertib Combination Therapy in Advanced Breast Cancer

(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release

Shire plc: U.S. FDA acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465

Lexington, Mass., USA, 20-Jan-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, … Read the full press release

AstraZeneca announced that the US FDA accepted for filing the New Drug Application for IRESSA® (gefitinib)

LONDON, 2-12-2014 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA® (gefitinib) as a targeted monotherapy for the first line treatment of patients with … Read the full press release