Tag: Food & Drug Administration
Many COVID-19 Home Test Users May Act on Quarantine Inappropriately
Users may fail to quarantine or quarantine unnecessarily because of misinterpretation of pretest probability
FDA Panel Rejects Lilly Cancer Drug Tested Only in China
Drug was to be used alongside chemotherapy for patients with metastatic non-small cell lung cancer
FDA Approves Rinvoq for Treatment of Atopic Dermatitis
Approval indicated for those 12 years and older with atopic dermatitis that has not responded to previous treatment
Senate Committee Backs Califf Nomination to Head FDA
Among those who voted against Califf's nomination were Democrats who expressed concerns about his links to pharmaceutical companies
Most COVID-19-Related EUAs Not Supported by High-Quality Evidence
Most EUAs were for diagnostic products; most supported by comparisons with previously authorized assays, analytical in vitro studies
FDA May Allow Pfizer Boosters for 12- to 15-Year-Olds by Monday
Agency also expected to reduce the amount of time adolescents and adults must wait between their second dose of vaccine and booster
FDA Approves Pfizer Pill as First At-Home COVID-19 Treatment
Recent trial showed Paxlovid cut the odds for hospitalization and death by nearly 90 percent in high-risk people
FDA Approves First-in-Class Treatment for Myasthenia Gravis
Vyvgart is the first neonatal Fc receptor blocker to be approved to treat generalized myasthenia gravis in patients testing positive for AChR antibody
FDA Approves Imaging Drug That Can Help Surgeons Spot Ovarian Cancers
Drug is designed to improve surgeon's ability to detect ovarian cancer while operating on a patient
Outpatient Gabapentin Rarely Used for Approved Indications
Concomitant use of central nervous system-depressant drugs listed for 58.4 percent of off-label gabapentin visits
