Senators question Trump's pick to lead FDA on abortion pill access at hearing
Dr. Marty Makary, President Trump's nominee to lead the Food and Drug Administration, faced questions from senators about ...
Capricor: Further Value Unlocked With Priority Review Of Deramiocel
Capricor Therapeutics, Inc.'s Deramiocel receives FDA Priority Review for DMD cardiomyopathy, with a decision by Aug. 2025.
Trump's FDA chief nominee Makary promises role for vaccine expert committee
Martin Makary, President Donald Trump's nominee to run the U.S. FDA, on Thursday promised to convene the agency's vaccine ...
Trump’s FDA nominee, Marty Makary, faces his first test
Marty Makary, Trump’s pick for FDA director, faces his first test as he testifies before the Senate health committee.
Trump’s FDA Cuts Are Putting Drug Development at Risk
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
BioSpace4h
Rare Disease Biotechs Left in a Lurch as Congress Fails To Renew Priority Review Program
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple ...
BioSpace1d
Priority Review Vouchers: By the Numbers
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer ...
‘We Were Told Nothing.’ What to Know About the Canceled Meeting to Discuss the Next Flu Shot
The meeting cancellation came one day before the CDC issued its weekly MMWR report, a scientific update on the latest ...
BioPharma Dive14d
In FDA job cuts, experts see threat of far-reaching impact
"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...
MedTech Dive9d
FDA brings back some fired device staff
An industry source said “most, if not all” of the people at the CDRH who were recently dismissed are now being asked to ...
GEN - Genetic Engineering and Biotechnology News8d
FDA Accepts for Review Precigen RRP Gene Therapy Candidate
PRGN-2012—which Precigen has begun to call by its generic name of zopapogene imadenovec—is a gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus ...
Reuters11d
US FDA asks fired scientists to return, including some reviewing Musk’s Neuralink
Americans need “an efficient, effective FDA review process that helps advance ... Retail & Consumercategory South Africa's RCL Foods reports 38.8% rise in half-year earnings 5:50 AM UTC ...