BioSpace

FDA’s Circle of Trust Is Shrinking, Making Many Decisions Feel Like ‘Fiat’

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.
Fierce Biotech

FDA accepts filing for Moderna flu vaccine after swift rethink

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
Hosted on MSN

FDA Publishes Drug Filing Checklists, Issues First-Ever Emergency Use for Animal Drug

WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...
newscase

Spruce Biosciences Revises Regulatory Submission Timeline for Key Drug Candidate

Spruce Biosciences Inc has announced a revised schedule for its regulatory submission of TA-ERT, a potential treatment for Sanfilippo syndrome type B. While the ...