News

FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting
In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...
PharmExec1d
Vinay Prasad’s FDA Departure Follows Controversy Over Drug Rejections
The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...
Fierce Pharma14d
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 ...
Lawmakers press FDA to target knockoff weight-loss drug
Dozens of lawmakers are urging U.S. health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
Fierce Pharma15h
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
The FDA must crack down on dangerous knockoff weight-loss drugs
Powerful new medications such as Ozempic and Mounjaro, known as GLP-1 drugs are helping to win the war against obesity in ...
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 seeks to classify 7-OH as Schedule 1 drug amid addiction concerns
Food and Drug Administrator Commissioner Marty Makary has requested that the Drug Enforcement Administration classify 7-OH as ...
FDA Head To ‘Listen To Concerns’ Regarding Coerced Use Of Abortion Pill Widely Available Online
Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...
BioPharma Dive9d
FDA panel elevates concerns over antidepressant use during pregnancy
Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater ...
FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
FDA Issues Risk Warning for Sunscreen Recall in Multiple States
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...