FDA Commissioner Robert Califf defended the decision to approve the controversial Alzheimer’s drug Aduhelm after a congressional probe found “inappropriate” collaboration between the agency and Biogen
U.S. Food and Drug Administration Commissioner Robert Califf defended his agency’s decision to approve the Alzheimer’sfound close cooperation between the drug’s sponsor and regulators.
Findings released late last year from the then-Democratic-led Oversight and Reform Committee and the Energy and Commerce Committee faulted the FDA for holding an unusual number of meetings with Biogen Inc. while it weighed approval of Biogen’s Alzheimer’s treatment, Aduhelm, as well as for co-authoring with the company a briefing document presented to outside advisers.
Singapore Latest News, Singapore Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Eisai, Biogen's Alzheimer's drug price should not dent demand, analysts sayThe $26,500-per-year price tag for Eisai Co Ltd and Biogen Inc's newly approved Alzheimer's disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said.
Read more »
Day One to submit its glioma drug to the FDA this yearShares of Day One Pharmaceuticals Inc. jumped 21% in premarket trading on Monday after the company shared positive data from an ongoing Phase 2 clinical...
Read more »
The FDA approves an Alzheimer's drug that appears to modestly slow the diseaseThe Food and Drug Administration has approved an Alzheimer's drug that appears to modestly slow down the disease. (Story aired on Weekend Edition Saturday on Jan. 6, 2023.)
Read more »
FDA Approves New Alzheimer's Drug Designed to Slow Cognitive DeclineThe US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer's disease.
Read more »
FDA approves Alzheimer’s drug lecanemab amid safety concernsReports of deaths potentially linked to the treatment have cast a shadow on what many hail as a landmark approval.
Read more »