FDA relaxes oversight of AI-enabled devices and wearables
Food and Drug Administration Commissioner Marty Makary.ANDREW CABALLERO-REYNOLDS/AFP via Getty Images Lizzy Lawrence leads STAT’s coverage of the Food and ...
Tag: FDA
Cytokinetics heart drug wins FDA approval, the biotech’s first
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and ...
FDA approves Nuzolvence, new pill for gonorrhea
A new kind of oral antibiotic to treat gonorrhea has secured Food and Drug Administration approval, the second time in ...
Mutual mistrust: FDA staff wary as Høeg becomes top drug regulator
WASHINGTON — In 2008, Tracy Beth Høeg, then a resident physician and ultramarathon runner, expressed dismay at vice presidential candidate ...
FDA panel urges easier access to testosterone therapy for men
Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, ...
FDA approves US-manufactured antibiotic under new priority review program
Tony Webster / Wikimedia Commons The Food and Drug Administration (FDA) yesterday approved a US-manufactured version of the oral antibiotic ...
FDA claims Covid vaccine caused kids’ deaths. Experts are skeptical
The Food and Drug Administration’s top vaccine regulator asserted in an email to staff sent Friday that the Covid-19 vaccine ...
FDA reviewers didn’t get to vote on first priority voucher drug
WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month ...
Bayer Lung Cancer Drug Lands Speedy FDA Nod to Stay Competitive With a Boehringer Ingelheim Med
A Bayer drug designed to target tumors driven by a rare genetic mutation now has accelerated FDA approval, providing another ...
FDA lifts major warnings on hormone replacement therapy
The U.S. Food and Drug Administration (FDA) is eliminating the prominent "black box" warnings on many hormone replacement therapy (HRT) ...
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