Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.
European Medicines Agency (EMA), in close collaboration with the European Commission, has established a standard procedure ...
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 ...
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 ...
Zacks Investment Research on MSN7d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's DrugBiogen 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, ...
Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...
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 ...
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