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 ...

ImmunityBio stock rose 19.8% after FDA meeting on ANKTIVA bladder cancer treatment. Company to submit additional data within ...

The FDA accepted Besremi's application for essential thrombocythemia, supported by SURPASS-ET and EXCEED-ET trial results, with a review target date of August 30, 2026. Essential thrombocythemia is a ...

Supplemental New Drug Application (sNDA) submission is supported by existing clinical data, including positive data from Company’s Phase 3 trial, Study 1601, in which the primary endpoint was met 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, ...

A recent decision of the CJEU in Europe raises concerns for pharmaceutical companies who wish to supplement the protection of their products with SPCs. With its decision C 567/16 the court follows a ...

Please provide your email address to receive an email when new articles are posted on . The FDA accepted a supplemental biologics license application for Vabysmo for the treatment of macular edema ...

BOSTON, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic ...

- 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 ...