FDA News


FDA Grants Fast Track Designation to SGX301 for First-Line Treatment of Cutaneous T-Cell Lymphoma (January 19, 2015)

The U. S. Food and Drug Administration has granted Fast Track designation the synthetic hypericin (SGX301) development program for the first-line treatment of cutaneous T-cell lymphoma. Fast Track designation... Continue Reading

FDA Approves Gazyva® (Obinutuzumab) Supplemental Biologics License Application with New Data in Previously Untreated Chronic Lymphocytic Leukemia (January 15, 2015)

Genentech announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for Gazyva in combination with chlorambucil chemotherapy in people with... Continue Reading

FDA Approves Blinatumomab for Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (January 12, 2015)

On December 3, 2014, the U. S. Food and Drug Administration granted accelerated approval for BLINCYTOTM (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell... Continue Reading

FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer (January 8, 2015)

The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC). The most common type of lung cancer,... Continue Reading

FDA Approves Nivolumab for Advanced Melanoma (December 23, 2014)

CancerConnect News: The FDA granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is... Continue Reading

Actinium Receives Orphan-drug Designation from FDA for Actimab-A in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients (December 8, 2014)

Actinium Pharmaceuticals, Inc., a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the US Food and Drug Administration... Continue Reading

Avastin Approved by the FDA for Recurrent Ovarian Cancer (December 2, 2014)

The FDA approval was based on the results of the AURELIA clinical trial, which involved 361 women with ovarian cancer that had recurred less than 6 months after their most recent platinum-based chemotherapy... Continue Reading

MM-398 Receives Fast Track Designation for Advanced Pancreatic Cancer (November 26, 2014)

The U. S. Food and Drug Administration (FDA) has granted MM- 398 plus 5-fluorouracil (5-FU) and leucovorin a Fast Track designation as a second-line treatment for patients with metastatic pancreatic cancer,... Continue Reading

FDA Approves Cyramza™ in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (November 13, 2014)

The U.S. Food and Drug Administration(FDA) has approved Cyramza™ (ramucirumab) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction... Continue Reading

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

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