Por: RTTNews Health September 24, 2022
DBV Technologies' () phase III study of modified Viaskin Peanut 250 µg patch, dubbed VITESSE, has been slapped with a partial clinical hold by the FDA.VITESSE is a phase III, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years.The company has not yet begun the screening or recruitment... + full article
ABC News USA Health September 30, 2022
WASHINGTON -- 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.The Food and Drug Administration approved... + más
Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval | New York Post
ALS drug wins FDA approval despite questionable data | ABC News
WASHINGTON -- 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.Amylyx Pharmaceuticals said the Food and... + más
ALS drug wins FDA approval despite questionable data | WPLG Local 10
New York Post USA Life September 30, 2022
A much-debated drug for Lou Gehrig’s disease won US approval on Thursday from the Food and Drug Administration. The nod represents a long-desired victory for patients, though it is likely to renew questions about the scientific rigor behind government reviews of... + más
ALS drug gets FDA approval despite uncertainty about effectiveness | ABC7
WPLG Local 10 USA Politics September 30, 2022
WASHINGTON – 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.The Food and Drug Administration approved... + más
Associated Press USA Science September 30, 2022
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.The Food and Drug Administration... + más
WPLG Local 10 USA Health September 24, 2022
WASHINGTON – The Food and Drug Administration acknowledged Tuesday that its response to the U.S. was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.A 10-page report from the agency offers its first formal... + más
FDA concedes delays in response to baby formula shortage | ABC News
‘If the FDA is expected to do more, it needs more’: FDA investigation into baby-formula crisis points to its own shortcomings. But shortages persist. | MarketWatch
ABC News USA Health September 21, 2022
WASHINGTON -- The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.A 10-page report from the agency... + más
FDA concedes delays in response to baby formula shortage | Associated Press
Internal FDA report on infant formula crisis details shortfalls in response | ABC News
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