FDA slow walking a long-awaited abortion pill safety study

The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at ...

FDA in turmoil after exit of veteran cancer researcher

Food and Drug Administration Commissioner Marty Makary is under renewed scrutiny by Trump officials amid continued turmoil at ...

Marty Makary touts FDA efforts to crack down on ‘out of control’ pharmaceutical ads and end animal testing in ‘Pod Force One’ interview

It’s getting out of control. It’s distorting the doctor-patient relationship, these endless pharmaceutical ads,” Makary told ...
Fierce Biotech

'Market's thinking is backwards': FDA's 1-trial approval plan would boost R&D spend, Jefferies says

All this data builds Jefferies’ argument: the FDA change could help boost return on investment and therefore drive R&D spend.
STAT

FDA to lower number of trials required for approval of drugs, other medical products

The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration ...
BioSpace

In Change That Pushed Pazdur Out, FDA May Lower Clinical Trial Requirements

Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies ...

FDA chief says Biden administration withheld data on heart risk from Covid vaccines

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

Fauci involved in ‘massive’ COVID-19 origins cover-up, FDA chief Marty Makary tells ‘Pod Force One’

Makary, a former professor at the Johns Hopkins School of Medicine, explained to “Pod Force One” host Miranda Devine that as ...

FDA deleting menopause hormone drug warning risks all women’s health | Opinion

No new data supports these label changes, which fly in the face of known science. More than 100,000 women in Kansas City and ...
BioPharma Dive

Tracey Beth Høeg, top Makary deputy, named head of FDA drug office

Høeg, a COVID-19 vaccine critic who’s been serving as a special assistant to the commissioner, will be the fifth person this ...

FDA changes heads of drug research and OTC drugs in latest shake-up

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has ...

FDA drug chief Pazdur felt undercut by Marty Makary in lead-up to resignation: Peter Pitts | CUOMO

Peter Pitts, a former associate commissioner of the FDA, joins "CUOMO" to discuss the resignation of Dr. Richard Pazdur, the ...