Previously to this drug’s approval, there were no treatment options for adults with interstitial lung disease associated with systemic sclerosis or scleroderma.
The American Thoracic Society says the FDA approved the asthma treatment with lack of consideration for patient safety and for a public policy process.
The FDA has approved the first treatment option in the United States for patients age 3 years or older with congenital or idiopathic pulmonary arterial hypertension.
The FDA is seeking a cap on nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, if finalized, would be what the FDA calls a “significant step”...