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, ...

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

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

Bristol Myers Squibb BMY announced that it has obtained a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency for two of its drugs. The ...

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

EU regulators have issued a positive opinion for the extension of the market authorization for a subcutaneous formulation of Johnson & Johnson's (NYSE:JNJ) Rybrevant for the treatment of a certain ...

Janssen-Cilag International NV, a Johnson & Johnson company, received European Medicines Agency's Committee for Medicinal Products ...

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...

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

The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.

The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.

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