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The FDA approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13% of the population with DMD.
The FDA approved VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients of 22 years or older.
The FDA today issued a final rule establishing that OTC consumer antiseptic wash products containing certain active ingredients can no longer be marketed, including the most commonly used ones Triclosan and Tricloarban.
Warnings of Serious Risks and Death When Combining Opioid Pain or Cough Medicines with Benzodiazepines
An FDA review of the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS), has found that this often resulted in serious side effects, including slowed or difficult breathing and deaths.