Tag: Drug Approvals
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
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
