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Lemtrada (alemtuzumab) received FDA approval on November 14, 2014, under fast track designation, for the treatment of patients with relapsing forms of MS.Due to the safety profile, alemtuzumab should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for MS.

There is widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease or dementia who live at home or in assisted living facilities, according to a new General Accountability Office (GAO) report.

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FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.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'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.

FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations

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.