FDA approval
FDA Approves Uveal Melanoma Therapy That Targets Specific Cancer Cells
The FDA approved tebentafusp-tebn (Kimmtrak, Immunocore), a bispecific T-cell engager designed to redirect the ...
JANUARY 31, 2022
FDA Approves Rituxan Plus Chemotherapy for Pediatric Hematologic Cancers
The FDA approved rituximab (Rituxan, Genentech) in combination with chemotherapy for pediatric patients (≥6 ...
DECEMBER 8, 2021
FDA Approves Fyarro for Perivascular Epithelioid Cell Tumor
The FDA approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi ...
NOVEMBER 30, 2021
Keytruda Gains Approval to Treat Patients With RCC After Nephrectomy
The FDA approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma ...
NOVEMBER 29, 2021
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 8, 2021
FDA Approves Verzenio for Early Breast Cancer
The FDA approved abemaciclib (Verzenio, Lilly) with endocrine therapy (tamoxifen or an aromatase inhibitor) for ...
OCTOBER 19, 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 14, 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 Tivdak for Recurrent or Metastatic Cervical Cancer
The FDA granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen/Genmab), a tissue ...
SEPTEMBER 24, 2021
FDA Approves Tibsovo for Adjuvant Treatment of IDH1-Mutated Cholangiocarcinoma
The FDA approved ivosidenib (Tibsovo, Servier) for adults with previously treated, locally advanced or metastatic ...
AUGUST 30, 2021
FDA Expands Opdivo Label to Include Adjuvant Treatment of UC
The FDA approved nivolumab (Opdivo, Bristol Myers Squibb) for the adjuvant treatment of patients with urothelial ...
AUGUST 27, 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 26, 2021