US FDA approves first drug to delay heart failure in dogs

Jan 19 () - Pharmaceutical company Boehringer Ingelheim said on Monday the U. Food and Drug ​Administration had approved its ...
STAT

Excitement and wariness as FDA shifts to much more flexible cell and gene therapy oversight

At a Food and Drug Administration cell and gene therapy (CGT) roundtable last June, most speakers pushed for the agency to ...

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

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

FDA clears first at-home brain device for depression

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Becker's Hospital Review

FDA clears AI imaging tool for brain metastases

The FDA has granted 510(k) clearance to Brain Mets, an AI-based software platform designed to aid in the detection, tracking and treatment planning of brain metastases. The tool, developed by Neosoma, ...
STAT

The Trump administration is turning drug review into make-a-deal

Carpenter is professor of government at Harvard. Hwang is a regulatory policy researcher at Brigham and Women’s Hospital. Kesselheim is professor of medicine at Brigham and Women’s Hospital and ...
FierceBiotech

FDA says it's hiring more than 1,000 new staffers, launches new comms program for review process

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs. “FDA announced over 40 job announcements for ...