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 ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

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

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

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

EU regulators have issued a positive opinion for the extension of the market authorization for subcutaneous formulation of ...

A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.

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

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

(RTTNews) - Ocugen, Inc. (OCGN) Monday said that the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) has provided a positive opinion for Advanced Therapy Medicinal Product ...

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