FDA News


Novel Agent Granted Fast Track Designation for Refractory Metastatic Colorectal Cancer (October 23, 2014)

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAS-102, a novel agent currently under investigation for the treatment of refractory metastatic colorectal cancer. According... Continue Reading

FDA Grants Breakthrough Therapy Designation to AP26113 for ALK-Positive NSCLC (October 22, 2014)

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to an investigational agent AP26113 for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small... Continue Reading

Amgen’s BiTE® Immunotherapy Blinatumomab Receives FDA Priority Review Designation In Acute Lymphoblastic Leukemia (October 10, 2014)

THOUSAND OAKS, Calif., Oct. 9, 2014 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application... Continue Reading

FDA Grants Orphan Drug Designation to Investigational Agent for Pancreatic Cancer (October 7, 2014)

Pancreatic cancer is one of the deadliest forms of cancer. Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and close to 37,000 die from the disease. The... Continue Reading

FDA Approves Use of Xtandi for Chemotherapy Naïve Men With Advanced Prostate Cancer (September 15, 2014)

The FDA approved the use of Xtandi® (enzalutamide) in men who have not yet received chemotherapy, significantly expanding the potential patient population eligible to be treated with the oral medicine. ... Continue Reading

Pembrolizumab Gets FDA Approval in Advanced Melanoma (September 5, 2014)

The U.S. Food & Drug Administration (FDA) has granted approval to Merck’s new immunotherapy drug, Keytruda (pembrolizumab), for treating metastatic melanoma.   It is the first anti-PD-1 drug, aimed... Continue Reading

Velcade Approved for Retreatment in Multiple Myeloma (August 21, 2014)

The U.S. Food and Drug Administration (FDA) has approved Velcade® (bortezomib) for the retreatment of adult patients with multiple myeloma who had previously responded to Velcade therapy and relapsed... Continue Reading

FDA Accepts Supplemental New Drug Application for Jakafi and Priority Review Granted for the Treatment of Polycythemia Vera (August 6, 2014)

The  U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Jakafi® (ruxolitinib) as a potential treatment of patients with polycythemia vera... Continue Reading

FDA Approves Mekinist in Combination with Tafinlar for Advanced Melanoma (January 13, 2014)

The U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) in combination with Tafinlar® (dabrafenib) to treat patients with advanced melanoma. Of the more than one million new diagnoses... Continue Reading

Nexavar Approved for Metastatic Differentiated Thyroid Cancer (December 9, 2013)

The U.S. Food and Drug Administration (FDA) has approved Nexavar® (sorafenib) for the treatment of metastatic differentiated thyroid cancer. Differentiated thyroid cancer is the most common type of thyroid... Continue Reading

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