US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse
IQVIA reported annual sales for the twelve months ending September 2024 of $4.3 billion for the brand and generic market for this product. About Elite Pharmaceuticals, Inc.
Monthly Prescribing Reference13d
FDA Drug Approval Decisions Expected in December 2024
If approved, olezarsen would be the first treatment available in the US for FCS ... patients with T1D. The FDA is reviewing the BLA for datopotamab deruxtecan (Dato-DXd), a specifically ...
Reuters4d
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
Pharmabiz2d
Azurity Pharma gets US FDA approval for Danziten tablets, the first and only nilotinib with no mealtime restrictions
Azurity Pharma gets US FDA approval for Danziten tablets, the first and only nilotinib with no mealtime restrictions: Woburn, Massachusetts Saturday, November 16, 2024, 17:00 Hrs ...
Autolus secures FDA approval for CAR-T cell therapy use in ALL
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy ...
GlobalData on MSN13d
FDA approves Journey Medical’s rosacea treatment Emrosi
Journey Medical's new rosacea treatment will rival industry giant Galderma's Oracea in the treatment of rosacea.
BioPharma Dive3d
PTC wins US approval of gene therapy for fatal enzyme disorder
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review ...