Tag: Food & Drug Administration
Congressional Report Slams FDA, Drugmaker Over Approval of Alzheimer Drug Aduhelm
Controversy over Aduhelm stretches back to its June 2021 approval by the U.S. Food and Drug Administration
FDA Approves Sunlenca for Treatment-Resistant HIV
Sunlenca is the first capsid inhibitor approved for HIV
FDA Tobacco Unit Overloaded and Lacking Direction, Panel Says
Experts recommend agency leaders set clear objectives and expectations to prevent more 'detrimental’ effects on the agency's work and staff morale
FDA Food Safety Program Needs a Revamp: Panel
Program needs an overhaul with greater attention paid to strong leadership and a more proactive culture
FDA Approves First Gene Therapy for Adults With Hemophilia B
Benefits include decreased need for routine factor IX replacement prophylaxis and reduction in annualized bleeding rate
FDA Oversight of Clinical Trials Described as ‘Grossly Inadequate’
Article describes inadequate oversight relating to development of COVID-19 vaccines and predating the pandemic
FDA Approves Drug Combo for Metastatic Non-Small Cell Lung Cancer
Approval is for tremelimumab in combination with durvalumab and platinum-based chemotherapy
FDA Panel Votes for Removal of Drug Meant to Prevent Preterm Births
FDA, Company Square Off in Hearing Over Drug Meant to Prevent Preterm Births
FDA officials want to withdraw the drug because of a lack of evidence of its efficacy and because of side effects
Most Safety Signals Reported to FDA Lead to Regulatory Action
Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of 57 resolved safety signals
