Drug Approval | December 12, 2023
Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Yesafili, received marketing authorization approval from the European Commission for the European Union
Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada
NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
This approval has come from the company's finished dosage form manufacturing facility
The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older
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