FDA approval
Vanrafia Receives Accelerated Approval
Vanrafia is now FDA-approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for ...
JUNE 13, 2025
FDA Approves Agamree to Treat Duchenne Muscular Dystrophy
The FDA approved Agamree oral suspension for the treatment of Duchenne muscular dystrophy in children aged 24 ...
OCTOBER 27, 2023
FDA Approves PK Activator to Treat Hemolytic Anemia
he FDA approved mitapivat to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare genetic ...
FEBRUARY 18, 2022
FDA Approves Generic Restasis to Treat Dry Eyes
The FDA granted approval to Mylan Pharmaceuticals to manufacture a generic form of Restasis for dry eye.
FEBRUARY 2, 2022
FDA Approves Recorlev for Cushing’s Syndrome
The FDA approved levoketoconazole to treat endogenous hypercortisolemia in adult patients with Cushing’s ...
JANUARY 3, 2022
FDA Approves Scemblix to Treat Ph-Positive CML in Chronic Phase
The FDA granted accelerated approval for use of asciminib (Scemblix, Novartis) in the treatment of patients with ...
NOVEMBER 9, 2021
Jakafi Approved To Treat Chronic GVHD in Adults and Children
The FDA approved ruxolitinib (Jakafi, Incyte) for chronic graft-versus-host disease after failure of one or two ...
OCTOBER 15, 2021
Cabometyx Approved for Metastatic Differentiated Thyroid Cancer
The FDA approved cabozantinib (Cabometyx, Exelixis) for adult and pediatric patients 12 years of age and older with ...
SEPTEMBER 30, 2021
FDA Approves Tibsovo for Adjuvant Treatment of IDH1-Mutated UC
The FDA approved ivosidenib (Tibsovo, Servier) for adults with previously treated, locally advanced or metastatic ...
AUGUST 30, 2021
FDA Approves Welireg for Tumors Associated With VHL Disease
The FDA approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor, for adults with von ...
AUGUST 27, 2021
Jemperli Approval Expanded to Treatment of dMMR Solid Tumors
The FDA granted accelerated approval to the programmed cell death receptor-1 agent dostarlimab-gxly (Jemperli, ...
AUGUST 19, 2021
Padcev Granted Regular Approval for Locally Advanced or Metastatic UC
The FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) to treat some adults with locally advanced or ...
JULY 19, 2021
