4 June 2024 - First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in ...
1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...
30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment ...
3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
30 May 2024 - Calliditas Therapeutics today announced that the CHMP of the EMA adopted a positive opinion recommending the ...
31 May 2024 - Zealand Pharma today announced that the CHMP of the EMA has issued a positive opinion recommending granting ...
31 May 2024 - Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in ...
31 May 2024 - Positive opinion based on totality of evidence, including results from the first randomised, controlled, cpen-label, cross-over Phase ...
31 May 2024 - Recommendation for adults with uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils based on data from ...
31 May 2024 - The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that ...
31 May 2024 - The EMA has recommended granting a conditional marketing authorisation in the European Union for Durveqtix (fidanacogene ...
31 May 2024 - EMA has recommended granting a marketing authorisation in the European Union for Ixchiq, the first vaccine ...
31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...
30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...