Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing ...

Pandemic influenza remains a significant global health threat, as signalled by the circulation and cross-species transmission of avian influenza A(H5N1) viruses from the clade 2.3.4.4b, including ...

Namodenoson is currently being evaluated in Liveration TM, a pivotal Phase III study for advanced liver cancer that has been ...

GLP-1 receptor agonists show promise in treating alcohol addiction by modulating reward pathways and reducing cravings, offering a novel therapeutic approach.

(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in ...

The company's commercial therapy is Hemgenix, which was approved by the FDA in November 2022 and by the EMA and Health Canada ... (with a 30% coefficient of variation) and the sample size very ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

Vir Biotechnology, Inc. today announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program. The ECLIPSE registrational program is designed to evaluate the efficacy and ...

While the FDA, European Medicines Agency (EMA), and the UK’s Medicines and ... the failure or significant delay to submit safety variations to update the safety sections of Summaries of Product ...

TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the ...