News

US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
Med Device Online5d
FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating
Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...
Fierce Biotech5h
FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
STAT11dOpinion
Five priorities to remake the FDA in a time of deep uncertainty
Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...
BioPharma Dive1d
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
BioPharma Dive3h
FDA misses approval deadline for biotech’s rare disease drug
The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.
Fierce Biotech12d
'An unwinnable situation': FDA delays force one biopharma to shelve phase 3 plans, WSJ reports
After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and ...
Healio4d
Confirmatory study delay after FDA accelerated approval should be ‘cautionary sign’
Cancer drugs that received accelerated approval from the FDA gained regular approval significantly faster if their ...
Pharmaceutical Technology on MSN6d
FDA layoffs and priority review voucher programme’s lapse disrupt rare disease pipeline
The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug ...
U.S. News & World Report5d
As FDA Delays Novavax' COVID Vaccine Approval, Patients Fight Back
As FDA Delays Novavax ... Asked the reason for delay and the request for more data, an HHS spokesperson said the agency remains committed to "ensuring products are safe for the American people ...
Becker's Hospital Review11d
FDA layoffs stall new drug development: 5 notes
In recent weeks, biotech companies have faced setbacks in moving forward with clinical trials due to operational delays at the FDA, according ... jeopardize potential product launches — issues ...
Novavax says its COVID-19 shot is on track for full FDA approval after delay
At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 ...