AstraZeneca, Merck win quick OK for a rare disease drug — as the FDA declares it can still move fast during a crippling pandemic
The pandemic may have altered the course of life as we know it, for awhile, but the FDA wants you to know that it is still raring to go when it comes to stamping accelerated approvals on rare disease therapies headed to patients with no existing meds to pick from.
On Friday, FDA oncology czar Richard Pazdur issued a special press release that noted regulators wasted no time in approving selumetinib from AstraZeneca and Merck, a proven treatment for neurofibromatosis type 1 — NF1 — a genetic disorder that triggers the growth of tumors on children’s nerves.
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