European Medicines Agency (EMA), in close collaboration with the European Commission, has established a standard procedure ...

Bayer seeks European approval of extended 6-month treatment interval for Eylea 8 mg to treat nAMD & diabetic macular edema: Berlin Tuesday, February 11, 2025, 10:00 Hrs [IST] Baye ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...

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 (VALN) announced that the Medicines and Healthcare products Regulatory Agency or MHRA has granted marketing authorization in the United ...

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 ...

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

(Alliance News) - AstraZeneca PLC on Monday said Imfinzi has been recommended for approval in the EU as monotherapy for limited-stage small cell lung cancer.