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FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
FDA to Review Resubmitted Dupilumab sBLA for Chronic Spontaneous Urticaria
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch.
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration
The Baltimore Sun
2d
FDA announces common over-the-counter cough and cold medicine doesn’t work
The
Food and Drug Administration
announced Wednesday its intention to ... that the oral form of the
drug
is ineffective ...
2h
Syndax confirms FDA approval of Revuforj for acute leukemia
Pharmaceuticals announced that the U.S. FDA has approved Revuforj as the first and only menin inhibitor for the treatment of ...
CCHR Int
4h
CCHR Urges FDA Overhaul to End Psychiatric Drug and Device Harms
The Mental Health Watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.
8d
After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
2d
on MSN
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
The U.S. Food and Drug Administration approved PTC Therapeutics' gene therapy to treat a potential fatal enzyme deficiency ...
3d
on MSN
These Cold and Flu Medicines Contain Phenylephrine, the Ingredient the FDA Plans to Ban
Phenylephrine is a medication that’s been used to relieve nasal congestion caused by colds, allergies, and hay fever, per the ...
4d
on MSN
FDA seeks to remove ingredient from cold medicines after data shows it does not work
The U.S. Food and Drug Administration is taking the first step to remove an ingredient in non-prescription cold medicines ...
WBRC FOX6 News
2d
FDA bans certain synthetic dye from cosmetics but allows in food, advocate calls it ‘illogical’
(WBRC) - The U.S.
Food and Drug Administration
(
FDA
... and said the agency is yet to answer a decades-old pledge to ...
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