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.

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 ...

Bayer seeks European marketing approval for use of finerenone in adult patients with HF with a left ventricular ejection fraction (LVEF) of =40%: Berlin Tuesday, February 4, 2025, ...

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 ...

AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...

Imfinzi recommended for approval in European Union for the treat of adults with limited-stage small cell lung cancer ...

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

(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 ...