FDA Approval

FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma

On November 9, 2017, 

The Food and Drug Administration granted regular approval to brentuximab vedotin (ADCETRIS, Seattle Genetics, Inc.) for the treatment….Read More

FDA granted approval to vemurafenib for Erdheim-Chester Disease

November 6, 2017,

The Food and Drug Administration granted regular approval to vemurafenib (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients….Read More

FDA approves new treatment for adults with relapsed follicular lymphoma

September 14, 2017

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies….Read More

FDA approves Mylotarg for treatment of acute myeloid leukemia

September 1, 2017

The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML)…. Read More

FDA Approves VOSEVI (Sofosbuvir, Velpatasvir, and Voxilaprevir) for Treatment of Adult Patients With Chronic HCV Infection Without Cirrhosis or With Compensated Cirrhosis Who Have Certain Genotype Infections and Previous HCV Treatments

July 18, 2017

The U.S. Food and Drug Administration (FDA) approved VOSEVI (sofosbuvir, velpatasvir, and voxilaprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: ….Read More

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

August 17, 2017

The U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy….Read More

FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL

August 17, 2017

The U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)….Read More

FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor

August 3, 2017

The U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS, Jazz Pharmaceuticals, Inc.) for the treatment….Read More

FDA expands ibrutinib indications to chronic GVHD

August 2, 2017

The U.S. Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure ….Read More

FDA granted regular approval to enasidenib for the treatment of relapsed or refractory AML

August 1, 2017

The U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid….Read More