FDA News


FDA Updates Use of Gleevec for Gastrointestinal Stromal Tumors (February 29, 2012)

In changes approved by the US Food and Drug Administration (FDA), the prescribing information for Gleevec® (imatinib) now notes that three years of adjuvant (post-surgery) treatment results in better... Continue Reading

Erivedge Approved for Basal Cell Skin Cancer (February 1, 2012)

The US Food and Drug Administration (FDA) has approved the targeted therapy Erivedge™ (vismodegib) for the treatment basal cell carcinoma of the skin that has spread to other parts of the body or that... Continue Reading

Inlyta Approved for Advanced Kidney Cancer (January 31, 2012)

The US Food and Drug Administration has approved Inlyta® (axitinib) for the treatment of advanced renal cell (kidney) cancer that has not responded to another drug used for this condition. Inlyta is a... Continue Reading

AMGEN AND FDA AGREE TO MODIFY NPLATE® (ROMIPLOSTIM) RISK EVALUATION AND MITIGATION STRATEGY (December 7, 2011)

Prescribing Physicians, Patients and Institutions no Longer Required to Enroll in Nplate® NEXUS Program THOUSAND OAKS, Calif., (Dec. 6, 2011) – Amgen (NASDAQ:AMGN) today announced the U.S. Food and... Continue Reading

New Warning Added to Sprycel Label (October 17, 2011)

The US Food and Drug Administration (FDA) announced that Sprycel® (dasatinib) may increase the risk of a rare but serious condition known as pulmonary arterial hypertension. Sprycel is a targeted therapy... Continue Reading

Prolia Approved for Treatment of Bone Loss in Patients with Breast or Prostate Cancer (September 21, 2011)

The U.S. Food and Drug Administration (FDA) has expanded the approval of Prolia® (denosumab) to include treatment of bone loss among breast cancer patients treated with aromatase inhibitor therapy and... Continue Reading

Xalkori Approved for Lung Cancer (August 30, 2011)

The targeted drug Xalkori™ (crizotinib) has been approved by the US Food and Drug Administration for the treatment of advanced non-small lung cancer that has an abnormal version of the ALK gene. Lung... Continue Reading

Adcetris Approved for Two Types of Lymphoma (August 26, 2011)

The targeted therapy Adcetris™ (brentuximab vedotin) has received accelerated approved by the US Food and Drug Administration (FDA) for the treatment of two types of lymphoma: Hodgkin lymphoma and systemic... Continue Reading

Zelboraf (Vemurafenib) Approved for Melanoma (August 22, 2011)

The targeted therapy Zelboraf™ (vemurafenib) has been approved by the US Food and Drug Administration (FDA) for the treatment of melanomas that carry a common mutation in the BRAF gene. Of the more than... Continue Reading

Sutent Approved for Pancreatic Neuroendocrine Tumors (PNET) (June 2, 2011)

The US Food and Drug Administration has approved the targeted drug Sutent® (sunitinib) for the treatment pancreatic neuroendocrine tumors (PNET). Pancreatic neuroendocrine tumors are an uncommon type... Continue Reading

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