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 ...

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) ...

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in ...

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, ...

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 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 ...

Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public ...

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