Adding Blenrep to standard therapy prolonged progression-free survival in patients with relapsed or refractory multiple ...

“Importantly, when combined with the sites we are opening in the US, this approval from the EMA, along with the individual country committee and/or ethics approvals, for Belgium ...

The European Medicines Agency (EMA) recommended in its April meetings approval of marketing authorizations for two orphan medicines: Alyftrek for the treatment of cystic fibrosis and Attrogy for ...

On April 15, two years after Eisai requested a marketing license for lecanemab in Europe, the European Commission has greenlit its use. The biologic’s long path included an initial rejection from the ...

Europe's medicines regulator on Monday launched PRIME, a new initiative to help get the most promising new drugs to patients faster. The European ... approval. They say the FDA's 'breakthrougth ...

The location of the European Medicines Agency after Brexit is to be decided ... there will be some degree of delay getting new drugs approved, and disruption to the EMA's other functions.

In several countries, such as those in the European Union ... to determine which medicines to use. The WHO can list a vaccine for recommended use. The agency gives this stamp when an inoculation ...

WASHINGTON (AP) — Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, has been named to oversee the health agency’s program for vaccines ...

1). On average, the FDA approval came 1 year ahead of clearance by the European Medicines Agency (EMEA). Figure 1: The EMEA meets its performance goals, but lags the FDA in new drug approvals.

today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) to conduct its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled ...

The 2025 Special 301 Report on Intellectual Property Protection and Enforcement cites electronics, medicines ... operation and Development (OECD) and European Union Intellectual Property Office ...

President Donald Trump urged the Senate to act on his massive tax and immigration package “as soon as possible” following ...