News

FDA's Makary sought to reject KalVista’s drug: report
FDA Commissioner Marty Makary reportedly initiated a brief request last week to decline approval of a rare disease drug ...
MedPage Today19hOpinion
How Fast Is Too Fast for FDA Drug Review?
In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...
BioSpace1d
FDA Conditional Pathway Not Necessary, Rare Disease Experts Say, While Applauding Intent
Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...
Fierce Pharma1d
FDA's acting CDER head Jacqueline Corrigan-Curay heads for the exit amid period of heavy turnover: reports
In the wake of Marks' exit, FDA Commissioner Marty Makary, M.D., named Vinay Prasad, M.D., to head up the CBER. In addition to that title, Prasad recently added the title of "chief medical and science ...
STAT1d
MAHA eyes tolerance as alcohol-related harms emerge
And more health news stories you need to start your week.
FDA’s Drug Chief Latest to Depart During ‘Challenging Times’
Curay, the FDA’s acting top drug regulator, is stepping down from her post after serving at the agency for more than eight ...
STAT2d
FDA chief’s goals of ‘radical transparency’ threatened by agency cuts
But current and former agency staff, as well as medical ethics experts, say recent cuts at the FDA are already making it more ...
BioSpace4d
FDA Chief’s New Voucher Program Could Ease Biotech Investors’ Anxiety
Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.
Gene editors steady despite latest leadership shake-up at FDA
Shares of gene editing companies were largely steady in the premarket on Friday after the FDA’s Center for Biologics Research ...
How we plan to cut FDA drug approval time by months
Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...
FDA's Prasad becoming agency's chief medical and scientific officer
FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...
FDA Commissioner Dr. Marty Makary on removing artificial dyes from food products
One of the country's biggest food manufacturers is getting on board with Health Secretary RFK Jr.'s plans to stop the industry from using synthetic dyes. FDA Commissioner Dr. Marty Makary joins "The ...