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FDA Approves Skyrizi for Moderately to Severely Active Crohn Disease

Skyrizi is first specific interleukin-23 approved to treat Crohn disease

New Cancer Drugs Approved Faster in U.S. Than Europe

FDA received licensing applications sooner and had shorter review times, compared to the European Medicines Agency

FDA Approves First Pill to Treat Severe Alopecia Areata

Olumiant is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot

Increased Flexibility Seen in Preapproval Evidence for New Drugs

Twenty-eight percent of trials used historical, external, or other control; nearly half used surrogate measure as a primary end point

Group of doctor with tablet and graphic network

Use of Extrapolation Common in FDA New Drug Approvals

Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity

Vijoice Granted First Approval for Treatment of PROS

Real-world data show 27 percent of patients with PIK3CA-related overgrowth spectrum treated with Vijoice had radiological response at 24 weeks

FDA Expands Approval of Jardiance for Patients With Heart Failure

Jardiance received approval to reduce the risk for cardiovascular death and hospitalization for patients with heart failure

FDA Gives Moderna COVID-19 Vaccine Full Approval

Vaccine, which has been available for the age group under emergency use authorization, will be marketed as Spikevax

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