FDA approves Syndax’s Revuforj to treat leukaemia
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating relapsed or ...
US FDA approves Syndax's blood cancer drug
The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and ...
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, ...
GlobalData on MSN5d
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 ...
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 ...
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 ...
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 ...
FDA grants orphan drug designation to potential treatment of STXBP1 developmental and epileptic encephalopathy
Research that was carried out by Baylor College of Medicine and Texas Children's Hospital doctors has led to the U.S. Food ...
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 ...
Targeted Oncology3d
FDA Approval Sought for Dato-DXd in EGFR-Mutated NSCLC
A new BLA for datopotamab deruxtecan aims for FDA accelerated approval to treat EGFR-mutated NSCLC based on data from ...
pharmaphorum1d
Unapproved Drugs in the US and FDA Enforcement
Grandfathered – Grandfathered refers to numerous older drugs approved before 1938 ... Drugs Available In the US Market in 201011 *Drugs against which FDA enforcement actions were taken.