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 ...
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 ...
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 ...
Nationwide Supplement Recall After FDA Discovers 'Hidden Drug Ingredient'
The unlisted ingredients can cause "life threatening" drops in blood pressure when used in combination with other prescription drugs, the agency warns.
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 ...
GlobalData on MSN4d
Intercept loses Ocaliva FDA full approval bid in rare liver disease
Intercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...
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 ...
JD Supra12d
New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs
On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR).
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...