The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies ...

List of oncology drugs approved by the FDA in September 2024. Throughout the month of September, several cancer therapies were approved by the Food and Drug Administration (FDA) for diseases including ...

The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to ...

This analysis shows that currently available genetic evidence supported 63% (271 out of 428) of the new drugs approved in the past decade overall, with a range of 41–72% annually (Fig. 1).

The FDA approved several drugs throughout November for the treatment of diseases including leukemia and biliary tract cancer, in addition to a diagnostic for solid cancers. Here's a look at five ...

Compound drugs are copies of U.S. Food and Drug Administration-approved medications. They are made by licensed pharmacies, but not approved or inspected by the FDA.

Alzheimer’s drugs that slow the progression of cognitive decline will be covered by Medicare as long as they’ve received traditional approval from the FDA and the clinical team gathers data ...

They often prioritize their requests to the FDA and its EU equivalent, the European Medical Authority, EMA – they have the largest markets. But in the U.S., we do not consider cost; as a result, the ...

This program aims to provide a mechanism for the FDA and EMA to jointly consider, and exchange views with applicants, on scientific questions during the development phase of hybrid/complex generic ...