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A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File)

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Speedier drug approvals hit slowdown as FDA faces scrutiny
By MATTHEW PERRONE - AP Health Writer
Tue,12/06/22-1:53PM , 274 Reads
WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders.
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Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device at his home Thursday, Oct. 20, 2022, in Marysville, Ohio. The device is part of a massive global recall of breathing machines triggered by sound-dampening foam that can break down, releasing potentially harmful particles and chemicals. (AP Photo/Jay LaPrete)

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Sleep apnea device recall drags on, stoking frustration
By MATTHEW PERRONE - AP Health Writer
Tue,10/25/22-7:46AM , 352 Reads
WASHINGTON (AP) — A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year.
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This photo provided by ALS patient Brian Wallach shows him and his wife, Sandra Abrevaya, at their home in Chicago on May 2021. Wallach, who formed I AM ALS with Abrevaya after being diagnosed with ALS in 2017, spent years working on legislation with congressional staffers, researchers and patients which passed the House last December in a landslide 423-3 vote. (Julie Dietz via AP)

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NIH to fund unproven ALS drugs under patient-backed law
By MATTHEW PERRONE - AP Health Writer
Sat,10/01/22-7:02AM , 608 Reads
WASHINGTON (AP) — When patients with a deadly diagnosis and few treatment options have tried to get unapproved, experimental drugs, they have long faced a dilemma: Who will pay?
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This image provided by Amylyx Pharmaceuticals shows the drug Relyvrio. The much-debated drug for Lou Gehrig’s disease won approval by the U.S. Food and Drug Administration on Thursday, Sept. 29, 2022, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines. (Amylyx Pharmaceuticals via AP)

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ALS drug wins FDA approval despite questionable data
By MATTHEW PERRONE - AP Health Writer
Thu,09/29/22-3:55PM , 337 Reads
WASHINGTON (AP) — A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.
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