10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
8 January 2024 - Approval of this orphan medicinal product is based on pivotal Phase 3 MycarinG study in generalised ...
22 December 2023 - Approval based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported by the ...
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
15 December 2023 - EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping ...
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment ...
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
15 December 2023 - If approved by the European Commission, patients 12 years of age and older with severe sickle cell ...
11 December 2023 - Vueway is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): ...
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...
10 December 2023 - First in class treatment option reduces number and intensity of hot flashes and night sweats ...
8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...