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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

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 Gives OK to Merck Antiviral At-Home COVID-19 Pill

Molnupiravir cut the risk for hospitalization and death in high-risk patients by 30 percent

FDA Approves New Drug to Help Control Severe Asthma

Tezspire is unique in that it only targets thymic stromal lymphopoietin, the molecule involved in airway inflammation

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

FDA Approves First Interchangeable Biosimilar for Inflammatory Diseases

Cyltezo is first interchangeable monoclonal antibody for RA, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, chronic plaque psoriasis

First Biosimilar Approved for Macular Degeneration, Other Eye Conditions

Biosimilar to Lucentis approved to treat neovascular age-related macular degeneration, macular edema, myopic choroidal neovascularization

Precedent Needed for FDA Approval Decisions When Evidence Lacking

In seven of 22 cases, approval used new interpretations of original evidence and did not require new evidence