News

Pickles recall update as FDA issues risk warning
The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...
Medscape1h
FDA Panel Casts Doubt on Safety of SSRI Use in Pregnancy
At a recent FDA panel on SSRIs in pregnancy, the chair suggested rising antidepressant use may be contributing to — not ...
Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
FDA Issues Bread Recall Update After Glass Discovered in Crusts
For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...
FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting
GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...
Fierce Pharma7d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
STAT20h
Safety of fluoride supplements, and freedom of choice, debated at FDA meeting
But it’s unclear if the evidence provided to support continued use of fluoridated supplements will matter. The FDA said in ...
BioSpace2h
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Fierce Pharma9d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
FDA Commissioner: No ‘preconceived plans’ on policy changes for abortion drug
Food and Drug Administration Commissioner Marty Makary said he has “no preconceived plans” to change the policies on mifepristone, an abortion pill that ends pregnancy before 10 weeks, in an interview ...