India, Aug. 26 -- As September ushers in the first hints of autumn, it also brings a packed FDA regulatory calendar.
But before we turn the page to September, here's what happened on the regulatory front in August - a month marked by several notable firsts.
On August 5, 2026, the FDA approved Takeda Pharmaceutical's (TAK) Orzeyful tablets for the treatment of narcolepsy type 1 in adults, making it the first and only medicine to directly target the underlying cause of the disorder.
On August 19, the FDA authorized Aletta, the first standalone robotic device capable of drawing blood from a patient's arm without hands-on operator intervention - a development aimed at easing the growing shortage of phlebotomists.
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