Tag: Drug Approvals
FDA Approves Treatments for Heart Failure Caused by Rare Disease
Capsules approved to treat cardiomyopathy caused by transthyretin mediated amyloidosis
FDA Approves Dengue Vaccine for Endemic Regions
Vaccine indicated for individuals aged 9 to 16 who have previously had laboratory-confirmed dengue disease
FDA Approves Mavyret for Children, Adolescents With Hep C
Drug approved for treatment of all six genotypes of hepatitis C virus in children ages 12 to 17
FDA Approves First Treatment for Pediatric Lupus
Approval based on study showing children who received Benlysta plus standard therapy had lower risk for flare
FDA Approves Pembrolizumab Plus Axitinib for Advanced RCC
Drug combination approved for advanced renal cell carcinoma based on findings from KEYNOTE-426
FDA Approves First Generic Nasal Spray Against Opioid Overdose
Product is also first generic naloxone nasal spray approved for use by people without medical training
FDA Approves Personalized Tx for Metastatic Bladder Cancer
Balversa indicated for treatment of bladder cancer with FGFR3 or FGFR2 genetic alteration
FDA Approves Osteoporosis Tx for High-Risk Postmenopausal Women
Boxed warning states increased risks for cardiovascular death, stroke, heart attack
First Two-Drug Regimen Approved for HIV-1 Treatment
Dovato indicated for use in patients with no history of antiretroviral treatment
Ibrance Approval Expanded to Include Men With Breast Cancer
Kinase inhibitor approved in combination with endocrine therapy for male patients with breast cancer
