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, ...
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 ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
US FDA approves Journey Medical's drug for long-term skin condition
The U.S. Food and Drug Administration has approved Journey Medical's drug for the treatment of a long-term skin condition ...
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 ...
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 ...
Pharmabiz3d
US FDA approves Johnson & Johnson MedTech’s OTTAVA robotic surgical system
US FDA approves Johnson & Johnson MedTech’s OTTAVA robotic surgical system: New Brunswick, New Jersey Friday, November 15, 2024, 12:00 Hrs [IST] Johnson & Johnson MedTech, a glo ...
Repurposed FDA-approved drug could uncover potential treatment for rare genetic disorders
In a new study, researchers at McMaster University have identified a potential treatment for Sandhoff and Tay-Sachs ...