FDA News


Vistogard® Approved for Life-Threatening Toxicities of Certain Chemotherapy Agents (February 11, 2016)

The United States Food and Drug Administration (FDA) approved Vistogard (uridine triacetate) for the treatment of life-threatening toxicities caused by the chemotherapy drugs fluorouracil or capecitabine. The... Continue Reading

FDA Clears Marketing Approval for Device to Reduce Hair Loss during Chemotherapy (January 4, 2016)

The United States Food and Drug Administration (FDA) cleared for marketing the first cooling cap to reduce hair loss due to chemotherapy. The cooling cap (Dignitana DigniCap Cooling System) is to be used... Continue Reading

FDA Approves Empliciti for Multiple Myeloma (December 7, 2015)

The United States Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for the treatment of patients with multiple myeloma who have received prior therapies. The indication specifies... Continue Reading

FDA Approves Opdivo for Renal Cell Carcinoma (November 25, 2015)

The FDA granted approval to nivolumab (Opdivo) for patients with renal cell carcinoma. Opdivo, a PD-1 inhibitor, was previously approved for the treatment of melanoma whose tumors express the BRAF V600... Continue Reading

Food and Drug Administration approves Odomzo for treatment of basal cell carcinoma (August 13, 2015)

The U. S. Food and Drug Administration approved Odomzo® (sonidegib, formerly LDE225) for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery... Continue Reading

FDA Designates Breakthrough Therapy Designation for Azedra in Pheochromocytoma and Paraganglioma (August 12, 2015)

The U.S. Food and Drug Administration (FDA) has designated Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma.... Continue Reading

FDA Grants Breakthrough Therapy Designation to LENVIMA™ for the Potential Treatment of Metastatic Renal Cell Carcinoma (August 3, 2015)

Eisai Inc. has announced that the U.S. Food and Drug Administration (FDA) granted LENVIMA™ (lenvatinib), the company’s multiple receptor tyrosine kinase inhibitor, Breakthrough Therapy designation... Continue Reading

Cancer treatment quackery fuels concern among doctors, FDA (July 8, 2015)

Be wary of possible side effects, drug interactions when using alternative health supplements, physicians caution One potentially fake cancer drug sold online can actually cause malignancies. One enema... Continue Reading

Melanoma Drug T-VEC Receives Recommendation for FDA Approval (May 1, 2015)

An advisory panel to the U.S. Food and Drug Administration (FDA) has recommended approval of the investigational drug T-VEC (talimogene laherparepvec) for the treatment of metastatic melanoma. Biopharmaceutical... Continue Reading

Novel PD-1 Inhibitor Opdivo Approved for Treatment of Lung Cancer (March 11, 2015)

CancerConnect News: The Food and Drug Administration has expanded approval of the PD-1 inhibitor Opdivo® (nivolumab) to include treatment of patients who have metastatic squamous non–small cell lung... Continue Reading

FDA Grants Breakthrough Therapy Designation for MPDL3280A, an anti-PDL1 Investigational Cancer Immunotherapy for Non-Small Cell Lung Cancer (February 26, 2015)

CancerConnect News: The investigational cancer immunotherapy MPDL3280A (anti-PDL1) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The designation was granted... Continue Reading

Farydak® Approval Provides Another Treatment Option for Patients With Multiple Myeloma (February 25, 2015)

Novartis announced today that the US Food and Drug Administration (FDA) has approved Farydak® (panobinostat) in combination with Velcade® and dexamethasone for the treatment of patients with multiple... Continue Reading

FDA Approves New Indication for Ibrutinib in Waldenström’s Macroglobulinemia (February 24, 2015)

CancerConnect News: The US Food and Drug Administration (FDA) today expanded the approved use of Imbruvica® (ibrutinib) for patients with Waldenström’s macroglobulinemia, a rare type of B-cell lymphoma.... Continue Reading

U.S. FDA Issues Warning about Certain Type of Endoscope (February 20, 2015)

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication about a certain type of endoscope­—specifically the device used in endoscopic retrograde cholangiopancreatography (ERCP).... Continue Reading

Intravenous Administration of Erwinaze® Approved by FDA (February 18, 2015)

CancerConnect News: The U.S. Food and Drug Administration (FDA) recently approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi).  Erwinaze is utilized as a component... Continue Reading

YONDELIS® (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma (February 4, 2015)

The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for YONDELIS® (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including... Continue Reading

CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients (January 28, 2015)

The U. S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug CPX-351, a liposomal formulation of cytarabine-daunorubicin, for the treatment of elderly patients... Continue Reading

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

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