News

Med Device Online4d
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 ...
BioPharma Dive22h
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” ...
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 ...
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 ...
Fierce Biotech11d
'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 ...
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 ...
Fierce Biotech6d
Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma
Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the ...
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 ...
Yahoo Finance6d
FDA layoffs and priority review programme’s lapse disrupt rare disease pipeline
Combined with reduced FDA capacity, the lapse of the priority review voucher programme could contribute to a slowdown in investment in rare paediatric drug development, says David Ridley ...
Reuters5d
As FDA delays Novavax' COVID vaccine approval, patients fight back
On Wednesday, the company got word that the FDA would ... the reason for delay and the request for more data, an HHS spokesperson said the agency remains committed to "ensuring products are ...