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 (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2506 as a biosimilar to reference p ...
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 ...
Immunotherapy has shown a 27% reduction in mortality for patients with limited-stage small cell lung cancer, based on Phase ...
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, ...
Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...
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EU’s Clinical Trials Regulation comes into full forceThe ruling requires all trials across the EU to be filed through the European Medicines Agency’s digital filing system.
If authorised, Vimkunya would be the first vaccine in the EU to protect adolescents aged 12 to 17 against Chikungunya.
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