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 ...

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, ...

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 ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

AstraZeneca (AZN) stock in focus as its partner Daiichi Sankyo (DSNKY) wins EU backing for their jointly developed breast ...

Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Breyanzi for the treatment of adults with relapsed or refractory ...

Merck on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers the 21-valent conjugate vaccine for immunization for the prevention ...

Bristol Myers (BMY) announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has ...