specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
Bio-Thera had entered into an exclusive licensing agreement with STADA Arzneimittel AG to commercialize BAT2506 in the European Union (UK), the United Kingdom (UK), Switzerland, and selected other ...
With the thumbs up from CHMP, the Opvido-Yervoy combo now moves forward to the European ... from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). The new approval covers ...
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 ...
“These moves are part of a holistic strategy to infuse the Agency with renewed energy ... since Congress hasn’t approved any money to do it. I’d hate to see people resign and then get ...
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