FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
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On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.
FDA approves first treatment for pediatric patients with lupus
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The U.S. Food and Drug Administration today approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) - often referred to as simply "lupus" - a serious chronic disease that causes inflammation and damage to various body tissues and organs.
FDA permits marketing of first medical device for treatment of ADHD
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The U.S. Food and Drug Administration permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.
FDA approves first generic naloxone nasal spray to treat opioid overdose
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The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
FDA approves first targeted therapy for metastatic bladder cancer
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The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.
FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture
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The U.S. Food and Drug Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.
FDA expands approved use of metastatic breast cancer treatment to include male patients
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The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
More Pharma News ...
- FDA approves treatment for patients with a type of inflammatory arthritis
- FDA approves a new generic valsartan
- FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic
- FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain
- FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease
- FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder
- FDA approves first generic Advair Diskus