Tag: Food & Drug Administration
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 Announces New Steps to Reduce Risks Tied to Surgical Staplers
Agency proposing higher classification of surgical staplers that will require premarket notification clearance
FDA Approves Pembrolizumab Plus Axitinib for Advanced RCC
Drug combination approved for advanced renal cell carcinoma based on findings from KEYNOTE-426
FDA Approves Marketing of First Device to Treat ADHD
Monarch eTNS System approved for children 7 to 12 years old not taking prescription ADHD medication
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
FDA Warns Against Use of Preowned or Unauthorized Test Strips
Unauthorized, preowned test strips could cause infection, inaccuracy
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
