The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...

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

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 ...

The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

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

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

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...