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 ...

The EUR/JPYdeclined slightly on board-based yen buying. It hit a low of 158.93 and is currently trading around 159.30.The ...

Immunotherapy has shown a 27% reduction in mortality for patients with limited-stage small cell lung cancer, based on Phase ...

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 ...

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 ...

The ruling requires all trials across the EU to be filed through the European Medicines Agency’s digital filing system.