Tag: Drug Approvals
First Biosimilar Approved to Treat Multiple Sclerosis
Tyruko, biosimilar to Tysabri (natalizumab) injection, approved for treatment of clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
FDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer
Akeega plus prednisone significantly improves radiographic progression-free survival in patients with castration-resistant prostate cancer
FDA Provides Accelerated Approval of Talvey for Multiple Myeloma
Talvey, a bispecific therapy, indicated for the treatment of patients with relapsed, refractory, heavily pretreated multiple myeloma
FDA Approves Izervay for Geographic Atrophy Tied to Age-Related Macular Degeneration
Two trials show significant slowing of geographic atrophy progression at the 12-month primary end point
FDA Gives Approval to Pill to Ease Postpartum Depression
Zurzuvae works faster than conventional antidepressants and is easier to take than another postpartum depression drug that is delivered intravenously
FDA Approves Xdemvy for Demodex Blepharitis
Significant improvements seen in reduction of collarettes in as early as two weeks
FDA Approves Topical Treatment for Molluscum Contagiosum
Ycanth approved for adults and children older than 2 years
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
