Tag: Drug Approvals
FDA Approves New Drug to Protect Against RSV in Infants
A single injection of Beyfortus administered before or during RSV season can provide protection during the season
FDA Approves First Over-the-Counter Birth Control Pill
Women will be able to buy the progestin-only oral contraceptive at drug stores, convenience stores, and grocery stores
Therapeutic Value of Drugs Lower for Supplemental Versus First Indications
For first three approved indications, second and third indication approvals less likely to have high value rating
FDA Gives Full Approval to Alzheimer Disease Drug Leqembi
While Leqembi did help reduce mental decline compared with placebo, the drug has been linked to two deaths from brain bleeds
FDA Approves Subcutaneous Vyvgart Hytrulo for Generalized Myasthenia Gravis
Trial shows similar reductions in anti-acetylcholine receptor antibody levels to the intravenous formulation
FDA Approves Litfulo for Teens, Adults With Alopecia Areata
Approval based on clinical trials, including ALLEGRO Phase 2b/3 trial involving 718 patients with alopecia areata
FDA Approves Talzenna for Metastatic, Castration-Resistant Prostate Cancer
Significant radiographic progression-free survival seen for homologous recombination repair gene mutation, including with BRCA mutation
FDA Approves New Drugs to Treat Type 2 Diabetes in Children
Approvals of Jardiance and Synjardy provide a new class of medications for pediatric type 2 diabetes
FDA Approves Linzess to Treat Constipation in Children, Teens
Linzess now approved for functional constipation in pediatric patients ages 6 to 17 years
FDA Approves Lynparza for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Approval is for Lynparza with abiraterone and prednisone (or prednisolone)
