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, ...
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FDA Drug Approval Decisions Expected in December 2024
If approved, sotagliflozin would be the first oral medication for patients with T1D. The FDA is reviewing the BLA for datopotamab deruxtecan (Dato-DXd), a specifically engineered TROP2-directed DXd ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
MedPage Today4d
FDA Rejects Full Approval of Liver Disease Drug
Notably, the FDA this year granted accelerated approval to two other drugs -- seladelpar (Livdelzi) and elafibranor (Iqirvo)- ...
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 ...
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 ...
FDA approves Syndax’s Revuforj for acute leukemia
The Food and Drug Administration approved Revuforj from Syndax (SNDX) Pharmaceuticals, a menin inhibitor, for relapsed or refractory acute ...
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FDA Approves Revumenib for Relapsed, Refractory Acute Leukemia With a KMT2A Translocation
The FDA has approved revumenib (Revuforj) for the treatment of adult and pediatric patients aged 1 year and older with ...
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 ...
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FDA Approves Revuforj for Relapsed/Refractory Acute Leukemia Subset
Revuforj was approved by the FDA for adults and children with relapsed/refractory acute leukemia with a KMT2A translocation.