Legal questions swirl around FDA's new expedited drug program, including who should sign off

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
MobiHealthNews

Three key questions for FDA mHealth regulation

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...
Yahoo Finance

uniQure (QURE) Is Down 19.0% After FDA Questions Data for AMT-130 Gene Therapy Approval ...

On November 3, 2025, uniQure announced that the FDA now questions whether Phase I/II data for AMT-130 are sufficient as primary evidence for a Biologics License Application, introducing uncertainty ...
Benzinga.com

FDA questions safety of GSK’s multiple myeloma drug

From my colleague Drew Joseph: Ahead of an advisory committee meeting Thursday focused on GSK’s multiple myeloma drug Blenrep, the FDA pointed to concerns about the high rates of eye issues that have ...
Investing

Inovio stock tumbles after FDA questions accelerated approval path

Investing.com -- Inovio Pharmaceuticals Inc (NASDAQ:INO) stock plunged 21% Monday after the FDA raised concerns about the company’s accelerated approval pathway for its RRP treatment candidate. The ...
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FDA staff review raises questions about MannKind diabetes device

WASHINGTON, March 28 (Reuters) - An initial review of MannKind Corp's experimental inhaled insulin device, Afrezza, by U.S. Food and Drug Administration staff raised multiple questions about its ...