News

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 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 ...
FDA chief has no 'plans' for abortion pill policy changes but continues safety review
Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies regarding the abortion pill mifepristone.
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.
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 ...
Fierce Pharma8d
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 ...
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 ...
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 panel promotes misinformation about antidepressants during pregnancy, psychiatrists say
A Food and Drug Administration panel discussing the use of antidepressants during pregnancy Monday largely amounted to ...
BioSpace16d
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.
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 ...
Benzinga.com25d
FDA Flags Major Safety Concerns For Argenx's Nerve Disorder Drug, Stock ...
FDA raised safety concerns for Vyvgart Hytrulo in CIDP, while Argenx moves ARGX-119 into late-stage trials for rare neuromuscular disease.