FDA Commissioner Dr. Marty Makary announces the acceptance of broader real-world data in medical applications, ending ...

The FDA’s TEMPO pilot will evaluate a risk-based enforcement approach to assess how patient access to digital health devices ...

Lower-income countries rarely gain timely access to FDA-approved drugs tested in their populations, highlighting major global and ethical disparities. Physical access was defined as where a tested ...

(FDA Access Data U.S. Food and Drug Administration FDA Access Data.) There have been no such adverse events with the RBI cells. • Leqembi and Kisunla do not improve cognition, they only slow the ...

FDA Commissioner Marty Makary has an ambitious plan to overhaul how quickly patients can access drugs in the US, but also wants to reduce reliance on pharmaceuticals by shifting the focus of research ...

Clene is planning to submit an application to the FDA in early 2026 requesting the accelerated approval of CNM-Au8 for ALS.

The US Food and Drug Administration is reviewing evidence about the safety and efficacy of one of the drugs used in medication abortion to investigate how it can be safely dispensed, US Health and ...

This is read by an automated voice. Please report any issues or inconsistencies here. A rare-disease patient questions what drives research costs behind $41,000-per-month medication, even before FDA ...

NEW YORK, Nov 5 (Reuters) - The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, was no more effective than a placebo, a ...