Tag Archives: New Drug Application

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