Tag: Food & Drug Administration
Updated Booster Shots, Not Original COVID-19 Vaccines, Should Be Standard: FDA Panel
Committee members also weighed a proposal to streamline the dosing schedule for COVID-19 vaccines by turning them into annual shots
Top FDA Official Involved in Baby Formula Debacle Resigns
Frank Yiannas' role included developing policies on food safety and responding to outbreaks, but the infant formula shortage posed the greatest challenge
FDA Approves New Two-Drug Combo Medicine for Asthma
Medication is the first approved in the United States to contain an inhaled corticosteroid as a reliever rather than as a controller of asthma symptoms
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
