Double-lung transplantation in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) was associated with better graft survival and patient survival than single-lung transplantation, according to a JAMA study.
FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.
FDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.
FDA's approval of the “generic" biologic prescription version of cancer medicine Neupogen opens the door to a movement that could save the US healthcare system tens of billions of dollars a year, according to Forbes.
Better post-hospital care is needed for sepsis patients to avoid readmissions that drive up costs and interfere with recovery, according to a study published in the March 10 issue of JAMA.
Taking commonly used medications with anticholinergic effects is associated with a significantly higher risk for developing pneumonia, according to a study published recently in the Journal of the American Geriatrics Society.
FDA approved dinutuximab (Unituxin, United Therapeutics) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.
FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations
FDA approved filgrastim-sndz (Zarxio, Sandoz), the first biosimilar product approved in the United States.
Paracetamol (acetaminophen) is still safer than nonsteroidal anti-inflammatory drugs (NSAIDs), but there is concern about its potential for some side effects not usually considered related to paracetamol, according to a study published in the Annals of Rheumatic Diseases.
Cresemba (isavuconazonium sulfate, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.
Because the use of corticosteroids in patients with severe community-acquired pneumonia is controversial, researchers in Spain set out to determine the benefits versus the pitfalls of using the adjunctive therapy.
The anticoagulant medication Fondaparinux (Arixtra) was associated with reduced major bleeding events and improved survival, compared to low-molecular-weight heparin (LMWH) in a large randomized clinical trial involving patients with non–ST-segment elevation myocardial infarction (NSTEMI), according to a new study.
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.
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).
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
