Valneva’s chikungunya vaccine Ixchiq has been greenlit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) ...

The UK approval marks the fourth regulatory approval Valneva has received for its single-shot chikungunya vaccine. The vaccine is currently approved in the United States (U.S.) 2, Europe 3 and Canada ...

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 ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

Janssen-Cilag International NV, a Johnson & Johnson company, received European Medicines Agency's Committee for Medicinal Products ...

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

The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.

The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.

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

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