The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended AstraZeneca's Imfinzi ...

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: Cambridge, UK Tuesday, February 4, 2025, 09:00 Hrs [IST] Astr ...

The Nuance Audio hearing aid smart glasses have received FDA clearance and a CE marking in the EU, clearing the way for a Q1 ...

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

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

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 ...

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

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

Dosimetry is integral to informed implementation of radiopharmaceutical therapies, enabling personalized treatment planning ...