Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...

A drug for treating diabetes similar to popular weight-loss medicines such as Ozempic did not show any benefits for people ...

Valneva’s chikungunya vaccine Ixchiq has been greenlit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) ...

EMA's CHMP has recommended AstraZeneca's Imfinzi for approval in the EU as a single agent for limited-stage small cell lung ...

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 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 ...

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

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 ...