Medications

High court ruling speeds up generic biotech drug approval

The Supreme Court is speeding up the time for generic biotech drugs to become available to the public. The court's unanimous ruling Monday means a loss of billions in sales to makers of original versions.

Diseases, Conditions, Syndromes

FDA OKs vagus nerve stimulator to treat cluster headaches

(HealthDay)—A new noninvasive device, gammaCore, which works to reduce cluster headache pain by transmitting mild electrical stimulation to the vagus nerve through the skin on the neck, has been approved by the U.S. Food ...

Medications

FDA OKs first treatment for rare genetic disorder

The Food and Drug Administration on Friday approved the first treatment for children and adults with spinal muscular atrophy, a rare genetic disorder marked by progressive muscle weakness that's the most common genetic cause ...

Health

FDA suggests limits on lead in cosmetics

(HealthDay)—The U.S. Food and Drug Administration has suggested setting a limit on how much lead can be in cosmetics ranging from lipstick and eye shadow to blush and shampoo.

Oncology & Cancer

Single-arm trials improve early access to rare cancer drugs

Although randomised clinical trials (RCTs) remain the gold standard for evaluating the benefit/risk of cancer drugs, single-arm trials (SATs) can provide invaluable opportunities to speed up cancer drug development and approval, ...

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