News

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 ...
Lawmakers press FDA to target knockoff weight-loss drug
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
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 ...
Fierce Pharma9d
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 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 chief talks staffing, abortion drug and tobacco
The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.
Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
BioPharma Dive4d
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 ...
BioSpace17d
Lilly Gets FDA Label Update for Alzheimer’s Drug To Mitigate Safety Concerns
The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of the monoclonal antibody drug class that has led to several deaths.