FDA approves new eczema drug Dupixent
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- Category: FDA
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
FDA approves first treatment for rare form of skin cancer
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- Category: FDA
The U.S. Food and Drug Administration has granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer.
FDA approves drug to treat Parkinson's disease
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- Category: FDA
The U.S. Food and Drug Administration has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an increase in Parkinson's symptoms, such as tremor and difficulty walking.
Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union
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- Category: FDA
The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other's good manufacturing practice inspections of pharmaceutical manufacturing facilities.
FDA approves Odactra for house dust mite allergies
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- Category: FDA
The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age.
FDA approves drug to treat Duchenne muscular dystrophy
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- Category: FDA
The U.S. Food and Drug Administration has approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Emflaza is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system.
FDA approves first drug for spinal muscular atrophy
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- Category: FDA
The U.S. Food and Drug Administration has approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.
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- FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
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