The FDA approved five fewer novel medicines than in 2023 while the EMA improved its tally by seven. Image credit: Shutterstock / Tamakhin Mykhailo. The US Food and Drug Administration (FDA) has ...

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 ...

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...

The U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA), and the European Medicines Agency (EMA ... to the currently approved SPINRAZA ...

(BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated ...

3 There are four categories of drugs available on market without FDA approval: 1. DESI Pending – DESI drugs may stay on the market under current policies. 2. Over the Counter (OTC) Monograph ...

In the U.S., FDA cycle times are calculated from the time a drug is submitted for approval to when it is granted approval. Almost immediately after the FDA grants approval, the drug is authorized ...

Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings ... Per management, a higher dose regimen of the drug has the potential to slow neurodegeneration faster through greater ...