The FDA today 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. SMA is a hereditary disease that causes weakness and muscle wasting because of the loss of lower motor neurons controlling movement. There is wide vari...

The FDA today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema and onset typically begins in childhood and can last throu...

As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (e.g. Actos) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and the FDA has approved label updates to describe the additional studies reviewed. The FDA alerted the public about the possible risk of bladder cancer in September 2010 and June ...

The FDA approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. Death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death. The FDA’s decision is based on a ...

The FDA today approved Intrarosa (prasterone) for the treatment of women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). During menopause, levels of estrogen decline in vaginal tissues, which may cause a condi...

Ingrezza Approved to Treat Tardive Dsykinesia
New Drugs , News / April 15, 2017

The FDA approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movement...

Sovaldi and Harvoni Approved for Pediatric Patients
Drug Alerts , News / April 15, 2017

The FDA approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are ...

Dupixent Approved for Eczema
New Drugs , News / April 1, 2017

The FDA 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 t...

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