The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics ...

Please provide your email address to receive an email when new articles are posted on . The FDA accepted the supplemental new drug application for Zoryve foam 0.3% to treat adults and adolescents with ...

Please provide your email address to receive an email when new articles are posted on . Merck announced the FDA accepted two supplemental new drug applications for Prevymis, also known as letermovir, ...

- Application Seeks to Expand Label to Include Single-Dose Administration of DALVANCE for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in Adults - DUBLIN, Oct. 9, 2015 ...

Supplemental Application for GARDASIL, Merck's Cervical Cancer Vaccine, Designated Priority Review by the U.S. FDA for Use in Women 27 through 45 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug ...

The Sustainable Energy Engineering program will not require a supplemental application. This is a temporary change that applies only to undergraduate applications to SEE for Summer and Fall 2024. If ...

After submitting your supplemental applications, it is normal to experience a lull before you receive your first interview offer. Most applicants find this waiting period unsettling, especially if ...