FDA News


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

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