Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly ...

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis ...

application to the European Medicines Agency (EMA) for lenacapavir for PrEP. The EU-M4all application aims to help facilitate availability of lenacapavir for PrEP in low- and lower-middle-income ...

Strong early U.S. YORVIPATH® launch with 908 prescriptions as of Feb. 7, 2025; YORVIPATH full year 2024 revenue of €28.7 million - Following pre-NDA meeting with FDA, on track to submit TransCon CNP ...

NEW YORK CITY, NY / ACCESS Newswire / February 21, 2025 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law ...

Apellis (APLS) and Sobi announced the European Medicines Agency has validated an indication extension application for Aspaveli for the ...

The evolution of cell and gene therapy is reshaping drug discovery, providing new hope for rare diseases and cancer through innovative gene editing approaches.

Merck (MRK) stock in focus as anti-cancer agent Welireg is approved in the EU for kidney tumor conditions, VHL disease and ...

Tampere University has licensed a drug molecule intended for treating Epidermolysis Bullosa (EB), a group of rare and severe skin disorders, to Theravia, a pharmaceutical company headquartered in the ...

C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.

Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® ...

European leaders held an emergency meeting in Paris on Monday to align their position after the Trump administration said they would be excluded from talks with Russia to negotiate an end to the ...