By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for ...

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...

Compass Pathways announced that its investigational psilocybin treatment has successfully met its primary endpoint in a Phase 3 trial in depression.

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for ...

Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...

The Food and Drug Administration's decision, made public on Feb. 10, 2026, to not review an application to approve Moderna's proposed mRNA-based flu vaccine set off a firestorm of criticism from ...

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now ...

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.