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 ...

Since the European Medicines Agency (EMA) approval of omalizumab in 2005 as the first ever biologic for severe asthma, the ...

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

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 ...

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 ...

(Reuters) -German drugmaker Bayer on Friday won an endorsement by the European Medicines Agency to extend the intervals ...

Of the 56 oncology medicines which were granted a European Medicines Agency (EMA ... Connor said that the process to get new medicines approved in Ireland is slow, sometimes taking twice as ...

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 ...

Biodexa Pharmaceuticals PLC (“Biodexa” or the“Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet ...

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.

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