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 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 ...

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

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 ...

The FDA's approval is grounded in an evidence totality and comprehensive data package, which includes outcomes from a study.

(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 ...

A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

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