FDA approves treatment for patients with a type of inflammatory arthritis
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The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.
FDA approves a new generic valsartan
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Today, the U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic
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The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug,
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain
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A key element of the U.S. Food and Drug Administration's mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in our nation's drug supply chain.
FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease
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The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer's disease and a number of other serious diseases and health conditions.
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder
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The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.
FDA approves first generic Advair Diskus
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The U.S. Food and Drug Administration approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
More Pharma News ...
- FDA approves first treatment for rare blood disease
- FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
- FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
- FDA approves new treatment for patients with acute myeloid leukemia
- FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
- FDA highlights record-breaking number of generic drug approvals in October
- FDA approves new drug to treat influenza