pharmaphorum2d
EMA’s strategy for speeding up drug approvals in the EU
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
TASS3y
RDIF says no critical EMA remarks during Sputnik V’s registration in EU
did not receive any critical remarks of the European Medicines Agency (EMA) during the procedure of Sputnik V vaccine’s registration in the European Union, the sovereign fund’s CEO Kirill ...
pharmaphorum8y
FDA and EMA to work more closely on paediatric drug regulation
The TOPRA/European Medicines Agency regulatory review of the year conference in London heard the new arrangements will apply to the US and EU only, as countries such as Japan and Canada do not ...
EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's drug, Leqembi, after concluding a safety review. The European Medicines ...
Morningstar6d
MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013
As part of the regulatory process for the registration of new medicines in Europe, the EMA requires pharmaceutical companies to provide a PIP detailing their strategy for investigation of the new ...