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PharmExec14h
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 ...
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 ...
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 Pharma13d
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 ...
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 ...
Healio1d
White paper urges FDA to act against companies producing counterfeit GLP-1s
Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...
FDA staff raises eye damage concerns for GSK's blood cancer drug
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug Blenrep, when used in combination with other treatments, may cause eye damage 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 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 Dive8d
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 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 ...