Por: RTTNews Health October 18, 2022
The U.S. Food and Drug Administration has awarded 19 new grants and two new contracts totaling more than $38 million in funding mainly to develop medical products to treat rare diseases.The funding over the next four years will support clinical trials, natural history studies and regulatory science tools related to rare diseases, including Amyotrophic Lateral Sclerosis or ALS.The grants and contracts were funded by the FDA's Orphan Products... + 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.Amylyx Pharmaceuticals said the Food and... + más
Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval | New York Post
ALS drug wins FDA approval despite questionable data | WPLG Local 10
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
ALS drug wins FDA approval despite questionable data | ABC News
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
RTTNews USA Health September 24, 2022
The U.S. Food and Drug Administration and the National Institutes of Health or NIH have launched Critical Path for Rare Neurodegenerative Diseases or CP-RND, a new public-private partnership to help people with rare neurodegenerative diseases. The agencies have selected the... + más
FDA concedes delays in response to baby formula shortage | Associated Press
FDA concedes delays in response to baby formula shortage | WPLG Local 10
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
Internal FDA report on infant formula crisis details shortfalls in response | ABC News
Associated Press USA Politics September 21, 2022
WASHINGTON (AP) — 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... + más
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