FDA agrees to review a rare disease drug that its developer was about to give up on; The time has come for over-the-counter antidepressants

Taking stock of the drug industry, from the lab to the medicine chest

April 8, 2024 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

Sarah Silbiger/Getty Images STAT+ | FDA agrees to review a rare disease drug that its developer was about to give up on The move comes after Stealth BioTherapeutics spent a decade navigating FDA bureaucracy and burning through $75 million. By Ed Silverman Opinion: The time has come for over-the-counter antidepressants SSRI antidepressants meet the FDA's requirements for over-the-counter medicines. It's time to give them that status. By Roy Perlis STAT+ | About half of cancer drugs given accelerated approval don't show improved survival or quality of life In some cases, failure to show benefit didn't stop the FDA from converting accelerated approvals into full approvals, the authors found. By Jonathan Wosen Ruby Wallau for STAT STAT+ | Alnylam's twice-a-year drug lowered blood pressure when combined with common pills A single dose of zilebesiran led to long-lasting blood pressure reduction when taken with commonly used pills, a new trial finds. By Elaine Chen

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