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This Aug. 2, 2018 file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease. The review comes ahead of a meeting this week for outside experts to vote on the drug for ALS. The drug has been the focal point of a lobbying campaign by patients, their families and lawmakers. FDA reviewers said Monday, March 28, 2022 the single study from Amylyx Pharmaceuticals was “not persuasive” due to missing data, errors in enrolling patients and other problems. (AP Photo/Jacquelyn Martin, File)

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FDA skeptical of benefits from experimental ALS drug
By MATTHEW PERRONE - AP Health Writer
Mon,03/28/22-12:03PM , 431 Reads
WASHINGTON (AP) — Federal health regulators issued a negative review Monday of a closely watched experimental drug for the debilitating illness known as Lou Gehrig's disease, after months of lobbying by patient advocates urging approval.
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In this photo provided by The ALS Association, representatives from the group meet with former Tennessee Congressman Phil Roe, right, in his offices on Capitol Hill in Washington on March 14, 2022. The ALS Association and other patient groups have been lobbying federal officials for over a year seeking access to an experimental drug from Amylyx Pharmaceuticals. The Food and Drug Administration will soon meet to review the drug’s safety and effectiveness. (Kevin Allen/The ALS Association via AP)

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Pressured by patients, FDA reviews ALS drug with modest data
By MATTHEW PERRONE - AP Health Writer
Thu,03/24/22-9:13AM , 609 Reads
WASHINGTON (AP) — When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval?
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A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore., Monday, Dec. 27, 2021. U.S. regulators have granted full approval to Moderna’s COVID-19 vaccine after reviewing additional data on its safety and effectiveness. The decision Monday, Jan. 31, 2022 by the Food and Drug Administration comes after many tens of millions of Americans have already received the shot under its original emergency authorization. Full approval means FDA has completed the same rigorous, time-consuming review for Moderna’s shot as dozens of other long-established vaccines. (AP Photo/Jenny Kane)

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US gives full approval to Moderna's COVID-19 vaccine
By MATTHEW PERRONE - AP Health Writer
Mon,01/31/22-10:23AM , 481 Reads
WASHINGTON (AP) — U.S. health regulators on Monday granted full approval to Moderna's COVID-19 vaccine, a shot that's already been given to tens of millions of Americans since its emergency authorization over a year ago.
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FDA curbs use of antibody drugs sidelined by omicron
By MATTHEW PERRONE - AP Health Writer
Mon,01/24/22-4:19PM , 363 Reads
WASHINGTON (AP) — COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they are unlikely to work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday.
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