pharmaphorum1d
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 ...
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 ...
Hosted on MSN23d
The European Medicines Agency EMA has not 'admitted' that mRNA vaccines are 'experimental'
A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not been formally approved and that millions ... "mRNA vaccines and their ...
Pharmaceutical Technology on MSN8d
Unsafe and unregulated cell therapies being sold in Europe
The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European ...
Los Angeles Business Journal27d
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 ...
The American Journal of Managed Care10d
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.
EL PAÍS English11d
The most expensive drug ever approved: A gene therapy that cures butterfly skin and could cost $20 million per patient
Mía had dystrophic epidermolysis bullosa, better known as butterfly skin due to the extreme fragility of this tissue in ...