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 ...

Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate ...

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 ...

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 ...

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

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 ...