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) ...

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 ...

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 ...

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

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

The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly three months after it recommended approval for the drug to treat some patients ...

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