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 ...
FDA approves Cobenfy for adults with schizophrenia
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first ...
Targeted Oncology15h
FDA Approves IND for AS1986NS, a New Approach in Prostate Cancer Research
The FDA has approved the investigational new drug application of AS1986NS for prostate cancer detection and treatment.
Targeted Oncology8h
FDA Approves Revumenib in KMT2A-Rearranged Acute Leukemia
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute ...
Cure Today8h
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.
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
The U.S. Food and Drug Administration approved PTC Therapeutics' gene therapy to treat a potential fatal enzyme deficiency ...
Cure Today11h
FDA Approves Danziten for Leukemia Subset That Does Not Require Fasting
Danziten, a new formulation of nilotinib, may improve treatment adherence in patients with Philadelphia chromosome-positive ...
FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
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, ...
The American Journal of Managed Care1d
FDA Approves Gene Therapy to Treat AADC Deficiency
The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase ...
The American Journal of Managed Care1d
FDA Approves Danziten for Chronic Myeloid Leukemia Without Mealtime Restrictions
The FDA has granted approval to Azurity Pharmaceuticals' nilotinib tablets (Danziten), a novel version of the tyrosine kinase ...
FiercePharma3d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...