pharmaphorum1d
EMA’s strategy for speeding up drug approvals in the EU
In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage ...
pharmaphorum9d
When measuring European regulatory approval, the timestamp matters
The EMA's drug approval process is a two-step process, consisting of both the CHMP and EC's decisions. In comparison, the FDA is the only body that conducts regulatory review in the United States ...
The American Journal of Managed Care9d
Uniform Global Standards, Processes Could Accelerate CGT Approvals, Access
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
Los Angeles Business Journal26d
ImmunityBio Seeks Drug Approvals
ImmunityBio, the Culver City immunotherapy developer founded by Patrick Soon-Shiong, seeks approval ... drug to Europe. On Jan. 27, ImmunityBio announced that the European Medicines Agency ...
Morningstar11d
MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013
The EMA PDCO approved the clinical program to ... As part of the regulatory process for the registration of new medicines in Europe, the EMA requires pharmaceutical companies to provide a PIP ...
MarketWatch22d
Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug
Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their ... will resume its decision-making process for ...