Por: RTTNews Health January 03, 2023
Biotech company Evaxion Biotech A/S () announced Tuesday that the U.S. Food and Drug Administration or FDA, determined that the Company may proceed with its Phase 2b clinical trial of EVX-01.In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA for the treatment of patients with metastatic... + full article
Politico USA Health December 30, 2022
The FDA’s collaboration with Biogen, the maker of a controversial Alzheimer’s drug, before it granted the product accelerated approval was “atypical” and ran afoul of the agency’s protocol for documenting interactions with drug companies, according to a joint House... + más
Alzheimer's drug approval by FDA 'rife with irregularities,' probe finds | Los Angeles Times
Probe: Alzheimer's drug approval 'rife with irregularities' | ABC News
NBC 6 South Florida USA World December 30, 2022
Adam Glanzman Bloomberg Getty Images The ’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed... + más
FDA approves Alzheimer's drug that slowed cognitive decline in clinical trial | CNBC
Forbes USA Business December 06, 2022
syringe sticking out of raw chickengetty Even combining cell-cultured meat with plant-based ingredients will still prove impossible to compete with the real thing in the marketplace. Recently, the U.S. Food and Drug Administration its “no questions” letter in response to... + más
Small amounts of dairy may protect against Type 2 diabetes: Study | Newsweek
Beyond Meat COO reportedly attempts to consume human nose | The Verge
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
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 wins FDA approval despite questionable data | ABC News
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
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