News

Med Device Online3d
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 ...
Healio3d
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 ...
STAT10dOpinion
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 ...
Fierce Biotech10d
'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 MSN4d
FDA layoffs and priority review 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 ...
Novavax says its COVID-19 shot is on track for full FDA approval after delay
Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...
Fierce Biotech4d
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 ...
Fierce Pharma4d
FDA asks Novavax for post-marketing data pledge amid stalled COVID shot review
On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...
BioSpace12d
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express ...
SeafoodSource4d
How major FDA changes – both proposed and implemented – could impact the US seafood industry
Significant proposed regulatory changes within the U.S. Food and Drug Administration (FDA), along with large layoffs that ...
UPI3d
FDA warns unapproved hair-loss product finasteride tied to side effects
"Currently, there is no FDA-approved topical formulation of finasteride," it continued. "Compounded topical finasteride products do not have FDA-approved labeling. There are potential serious ...
US FDA limits industry employees from roles in its advisory committees
U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies ...