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Showing 3701 - 3750FDA Approves First Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The U.S. Food and Drug Administration (FDA) today approved the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for...
FDA Grants Orphan Drug Status to Eisai’s Investigational Compound E7777 for Cutaneous T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Eisai’s investigational compound E7777 for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support ...
Study Reveals Genes That Drive Glioblastoma
A team of researchers at the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center has identified 18 new genes responsible for driving glioblastoma multiforme, the most common—and most aggressive—form of brain cancer in adults. The study was published online...
FDA Warns of Rare but Serious Skin Reactions with Acetaminophen
The U.S. Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can...
FDA Limits Usage of Oral Ketoconazole Due to Potentially Fatal Liver Damage
The U.S. Food and Drug Administration (FDA) announced today that oral ketoconazole should not be used as first-line treatment for any fungal infection and should only be used for the treatment of endemic mycoses when alternative antifungal therapies are not available or tolerated. The use of...
FDA Invites Public Input on Menthol in Cigarettes
The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the...
FDA Approves Afatinib for EGFR-mutant Late-stage Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21...
New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and...
FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were given Priority Review designation by FDA earlier this week. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia (CLL), based on final stage 1 data from the pivotal CLL11 trial. FDA also granted Priority Review to a pertuzumab (Perjeta)...
Investigational New Drug Application Filed for CFI-400945
Investigators from Princess Margaret Cancer Centre in Toronto and the University of California, Los Angeles, have submitted an Investigational New Drug (IND) application for CFI-400945, a novel drug candidate targeting the enzyme PLK4, which plays a crucial role in cell division. The news was...
FDA Approves New Silicone Gel-filled Breast Implant
The FDA recently approved the MemoryShape Breast Implant for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC. The FDA’s approval is based on 6 years of data from 955 ...
FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone
The U.S. Food and Drug Administration (FDA) today expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s ...
ASCO 2013: Lung Cancer Mutations ALK and ROS1 Also Drive Colorectal Cancer
A study from the University of Colorado Cancer Center shows that the ALK and ROS1 gene rearrangements known to drive subsets of lung cancer are also present in some colorectal cancers. Results imply that drugs used to target ALK and ROS1 in lung cancer may also have applications in this subset of...
FDA Grants Orphan Drug Status for Novel Targeted Therapy for the Treatment of Rare Hematologic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Stemline Therapeutics' SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug...
FDA Clears Multicenter Trial of Treatment for Chemotherapy-related Hair Loss
The FDA has approved initiation of a multicenter trial of the DigniCap System, a scalp-cooling device for chemotherapy-related hair loss. The trial is the second and final phase of study for the DigniCap System. A pilot study previously conducted by researchers at the University of California San...
ASCO 2013: Adapting to Ongoing Shortages of Common Cancer Drugs
A survey of 214 U.S. oncologists and hematologists found that more than 80% encountered cancer drug shortages between March and September of 2012, and many reported that shortages affected the quality of patient care they were able to provide. As physicians were forced to substitute more expensive...
FDA Approves Lenalidomide for Patients with Relapsed or Refractory Mantle Cell Lymphoma
The U.S. Food and Drug Administration today approved lenalidomide (Revlimid) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade). Clinical Trial The approval was based on the results ...
ASCO 2013: Sorafenib Stalls Growth of Treatment-resistant Differentiated Thyroid Cancer
A randomized phase III study found that the targeted drug sorafenib (Nexavar) stalls disease progression by 5 months in patients with metastatic differentiated thyroid cancer that has progressed despite standard radioactive iodine therapy. If approved in this setting by the U.S. Food and Drug...
ASCO 2013: Adding Bevacizumab to Standard First-line Chemoradiation for Glioblastoma Does Not Improve Overall Survival
A randomized phase III study found no improvement in overall survival after the addition of bevacizumab (Avastin) to standard first-line chemoradiation for glioblastoma. Patients who received bevacizumab also experienced more side effects compared to those treated with chemoradiation alone. The...
ASCO 2013: Adding Bevacizumab to Chemotherapy Significantly Improves Response Rates and Survival in Women with Advanced Cervical Cancer
Adding bevacizumab (Avastin) to chemotherapy regimens with or without a platinum drug improved outcomes for women with metastatic or relapsed cervical cancer treated in a randomized phase III study. Presenting the results at the 2013 ASCO Annual Meeting (Abstract 3), lead author Krishnansu Sujata...
In the Clinic: Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, trametinib (Mekinist) was...
FDA Grants Fast Track Designation to SGX942 for the Treatment of Oral Mucositis
The FDA has granted fast track designation to the SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in patients with head and neck cancer. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and...
ASCO 2013: Pazopanib Maintenance Therapy Delays Relapse of Advanced Ovarian Cancer
A phase III clinical trial has found that pazopanib (Votrient), an oral multikinase inhibitor, extends disease-free survival by an average of 5.6 months, compared to placebo, in women with advanced ovarian cancer who had initial successful treatment with surgery and chemotherapy. “Our...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration today approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma, the most dangerous type of skin cancer. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors...
FDA Approves Low-dose, Two-dimensional Mammography Software
Hologic, Inc, announced today that the U.S. Food and Drug Administration (FDA) has approved the use of C-View, a new low-dose two-dimensional (2D) imaging software. C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of Hologic’s FDA-approved...
FDA Approves Radium-223 Dichloride for Patients with Castration-resistent Prostate Cancer
On May 15, 2013, the U.S. Food and Drug Administration approved radium Ra 223 dichloride (Xofigo) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Radium-223 dichloride is an...
FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for erlotinib (Tarceva). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of...
FDA Warns about Potential Medication Errors Resulting from Confusion Regarding Nonproprietary Name for Kadcyla (ado-trastuzumab emtansine)
The U.S. Food and Drug Administration (FDA) is alerting health-care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine, also known as T-DM1 during preapproval clinical trials) in some medication-related electronic systems...
Daratumumab Receives Breakthrough Therapy Designation in Multiple Myeloma
FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and...
Breakthrough Therapy Designation for Lambrolizumab for the Treatment of Advanced Melanoma
Merck has announced that the U.S. Food and Drug Administration has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting the programmed death receptor (PD-1) that...
Pharmacyclics Completes Enrollment of Phase III Ibrutinib CLL Study and Phase II Ibrutinib MCL Study
Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As...
New Labeling for Reformulated OxyContin to Curb Abuse
The U.S. Food and Drug Administration has approved updated labeling for the reformulated painkiller OxyContin (controlled-release oxycodone hydrochloride). The new labeling will indicate that the drug has physical and chemical properties that make injection or snorting challenging. This new measure ...
Biomarker Analysis Identified Women Most Likely to Benefit from T-DM1
For women with metastatic, HER2-positive breast cancer, the amount of HER2 on their tumor might determine how much they benefit from T-DMI—also now known as ado-trastuzumab emtansine (Kadcyla)—according to data from a subanalysis of the phase III clinical trial that led the FDA to...
Statement by ASCO President Sandra M. Swain, MD, FACP, in Support of the Rally for Medical Research, April 8, 2013
A strong, stable federal investment in cancer research, prevention, and treatment is critical to continue the progress we are making for the more than 1.66 million Americans newly diagnosed with cancer every year. ASCO calls on Congress to renew its commitment to this life-sustaining research. As...
Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA
Pharmacyclics, Inc, announced today that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm...
New Minimally Invasive, MRI-guided Laser Treatment for Glioblastoma Found to Be Promising in Study
The NeuroBlate Thermal Therapy System provides a new, safe, and minimally invasive procedure for treating recurrent glioblastoma, according to the first-in-human study of the system. The study, published online today in the Journal of Neurosurgery, was written by lead author Andrew Sloan, MD,...
Ganetespib Demonstrates Potency against ALK-positive Lung Cancer and Overcomes Crizotinib Resistance
A drug that indirectly impairs the function of several cancer-driving proteins, including anaplastic lymphoma kinase (ALK), may be an effective new treatment for patients with ALK-positive non–small cell lung cancer (NSCLC). The drug, ganetespib, may also be effective for treating patients...
New Imaging Agent Enables Better Cancer Detection, More Accurate Staging
Researchers at the University of California, San Diego School of Medicine have shown that a new imaging dye, designed and developed at UC San Diego Moores Cancer Center, is an effective agent in detecting and mapping cancers that have reached the lymph nodes. The radioactive dye technetium Tc-99m...
Cancer Drug Shortages Mean Higher Costs and Greater Risk for Patients
A national survey of health professionals showed that drug shortages are taking a heavy toll on cancer patients, forcing treatment changes and delays that for some patients meant worse outcomes, more therapy-related complications, and higher costs. St. Jude Children’s Research Hospital...
Moffitt Cancer Center Researchers Study Use of Dasatinib for Patients with High-risk MDS
Researchers at Moffitt Cancer Center have completed a phase II clinical trial to determine the safety and efficacy of dasatinib (Sprycel) for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia, or acute myeloid leukemia resulting from MDS and have failed ...
FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers
The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Technetium Tc 99m tilmanocept is an...
IOM Gauges Progress in Goals for Improving the Cancer Clinical Trials System
The National Cancer Policy Forum of the Institute of Medicine (IOM), in conjunction with ASCO, held a workshop in February to discuss a collaborative approach to making the National Cancer Institute (NCI)-funded clinical trials system more viable and productive. This was a follow-up meeting to...
Trio of Biomarkers May Help Identify Kidney Cancer in Early Stages
A new immunoassay that tests for the presence of three biomarkers appears to be a valid screening method for the early detection of malignant kidney cancer, according to data published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research....
Philips Receives FDA 510(k) Clearance for MicroDose SI Mammography System
Royal Philips Electronics today announced that it has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography system that has the capability to enable future single-shot spectral imaging applications. High Breast Density High breast density is a known...
FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors
The FDA has expanded the approved use of regorafenib (Stivarga) to treat patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) that no longer respond to treatment with imatinib (Gleevec) or sunitinib (Sutent). Regorafenib, a multikinase inhibitor, blocks several enzymes...
FDA Approves New Treatment for HER2-positive, Metastatic Breast Cancer
The FDA approved ado-trastuzumab emtansine (Kadcyla), referred to as T-DM1 during clinical research, for patients with HER2-positive, metastatic breast cancer who were previously treated with trastuzumab (Herceptin) and taxane chemotherapy. “[Ado-trastuzumab emtansine] is trastuzumab...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide, an oral immunomodulatory agent, is intended for patients who have received at least two prior therapies, including lenalidomide...
High-dose Vorinostat Effective at Treating Relapsed Lymphomas, Study Finds
Reporting the results of a phase I clinical trial to test the effectiveness of a new class of drugs to augment standard chemotherapy, a team led by Fred Hutchinson Cancer Research Center scientists found that giving patients high doses of vorinostat (Zolinza) in combination with another round...
FDA Approval of Generic Version of Liposomal Doxorubicin Injection Is Expected to Help Resolve Shortage
The FDA has approved the first generic version of liposomal doxorubicin (Doxil), which is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to...
Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....
