The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...

The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

Halozyme (HALO) announced that Janssen-Cilag International, a Johnson & Johnson (JNJ) company, received a positive opinion from the ...

Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...