FDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.
FDA has expanded the approved use of nivolumab (Opdivo, Bristol Myers Squibb) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
FDA has launched its first mobile application (app) designed to provide quick access to important information on medications that are in short supply. Current or resolved drug shortages, as well as product discontinuations, can be identified by using the new app.
A new nanodevice developed by MIT researchers can help prevent cancer tumors from growing back after chemotherapy, according to a new study published in the Proceedings of the National Academy of Sciences for the week of March 2.
A national survey of pharmacy professionals released March 3 found that a move to specialty drug distribution of three primary cancer drugs is resulting in higher costs to hospitals and reduced availability of the medications.
Xolair (omalizumab), a drug used to treat allergic asthma in adults and children 12 years and older, has been linked to significant health issues such as mini-strokes, heart attacks and blood clots, according to the law firm of Baron and Budd, which has offices in Dallas, Texas, and several other cities.
Among patients receiving antithrombotic therapy (to prevent the formation of blood clots) after a heart attack, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with an increased risk of bleeding and events such as heart attack, stroke or cardiovascular death, even after short-term treatment, according to a study in the February 24 issue of JAMA.
FDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.
A bill has been introduced in California which will require drug companies to reveal operational costs in order to better understand pricing for ultra-high-priced drugs.
Pediatric cancer patients who receive antibiotics within 60 minutes of reporting fever and showing neutropenia (low neutrophil count), go on to have decreased intensive care needs and lower mortality compared with patients who receive antibiotics outside the 60-minute window, according to a University of Colorado Cancer Center study published in Pediatric Blood & Cancer.
FDA has approved a new once-daily, long-acting basal insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL, Sanofi) for the treatment of adults with type 1 and type 2 diabetes mellitus. It is described as a more potent follow-up to the manufacturer’s insulin product Lantus (insulin glargine [rDNA origin] injection, 100 U/mL).
FDA has approved ceftazidime-avibactam (Avycaz, Actavis and Forest), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
The oral formulations of the antifungal medication ketoconazole should be removed from the market immediately, Public Citizen said this week in a petition to the Food and Drug Administration (FDA).
Kaiser Permanente Southern California's population-based program for men with prostate cancer has led to improved outcomes, according to a study published in Urology Practice.
Most treatments for pain caused by knee osteoarthritis helped alleviate pain better than acetaminophen (Tylenol) – with one exception, according to a study published in the January 6 issue of the Annals of Internal Medicine
The prostate cancer medication leuprolide acetate (Lupron Depot), used in conjunction with acetylcholinesterase inhibitor (AChEI), slowed memory loss in female Alzheimer’s patients, according to a new study.
Resistance to the malaria medication artemisinin extends across much of Myanmar in Southeast Asia, according a new study, published online February 19 in The Lancet Infectious Diseases.
Patients who increased doses of opioid medicines to manage chronic pain were more likely to experience an increase in depression, according to a study published in the February issue of Pain.
The VenaSeal system is newly approved to permanently treat varicose veins by sealing the affected veins using an adhesive agent, known as n-butyl-2-cyanoacrylate, which polymerizes into solid material after being injected into the vein.
Actavis has received final approval from FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2 mg and 8 mg sublingual tablets) indicated for treatment of opioid dependence.
FDA approved Farydak (panobinostat) for the treatment of patients with multiple myeloma, which is attributed to 10,710 deaths in the U.S. annually.
FDA has authorized marketing of Bloom Syndrome carrier test, a direct-to-consumer genetic test from 23andMe.The test is designed to identify healthy individuals who carry a gene that could cause Bloom Syndrome in their offspring.
The introduction of high-cost, high-use PCSK9 inhibitors (proprotein convertase subtilisin/kexin 9) enzyme inhibitors to treat high cholesterol, takes the industry step closer to a future where “healthcare costs break the bank,” according to industry insiders.
FDA expanded approval of lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma. Revlimid acts as an immunomodulating agent and inhibits the growth of myeloma cells by inducing cell cycle arrest and cell death.
Individuals and families who were not aware of the tax implications of not having insurance will have an opportunity to obtain coverage during a special enrollment period.
In what is being called a first-of-its-kind joint effort, the Texas Medical Association and Blue Cross and Blue Shield of Texas are launching a resource initiative to assist independent physicians with providing accountable care.
More than 11 million UnitedHealthcare members are enrolled in accountable care organizations (ACOs), and the nation's top insurer plans to contract with 250 more ACOs in 2015.
A study of more than 1,500 cigarette smokers who were not ready to quit smoking but were willing to cut back on cigarette consumption and combine their approach with varenicline (Chantix, Pfizer) increased their long-term success of quitting smoking.
President Obama’s recent proposal to nearly double funding for antibiotic resistance programs to $1.2 billion in the 2016 federal budget confirms that the battle against “superbugs” is indeed moving up the government agenda.
Marketplace websites could be doing significantly more to help consumers make informed choices about their health plans, according to a new study.