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 ...

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

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

MALVERN, Pa. - Ocugen, Inc. (NASDAQ: NASDAQ:OCGN), a biotechnology company with a current market capitalization of $212 million, announced today that the European Commission has endorsed the European ...

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

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 ...

Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...

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

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

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...