Por: RTTNews Health September 28, 2022
Biopharmaceutical company CRISPR Therapeutics () announced Wednesday that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX130, the Company's wholly-owned allogeneic CAR T cell therapy targeting CD70, for the treatment of Mycosis Fungoides and Sézary Syndrome (MF/SS).Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite... + 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
The Atlantic USA Science September 24, 2022
CRISPR is changing the world—but it can do more.Erik Carter / The AtlanticSeptember 12, 2022Two years ago, I was working on my laptop in an airport lounge in Newark, New Jersey, when I glanced up and saw a couple walking with their two boys. The younger boy slowly made his way... + más
Teenagers on Revolution roster have provided a spark that bodes well for the future | The Boston Globe
‘I Think the Women Are Winning’ | The Atlantic
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
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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