FDA Approves First Generic Version of Contraceptive Vaginal Ring
The vaginal ring releases on average 0.12mg/d of etonogestrel, a progestin, and 0.015mg/d of ethinyl estradiol, an estrogen.
All articles by Steve Duffy
Novel GnRH Antagonist Reduces Heavy Menstrual Bleeding in Uterine Fibroids Study
Linzagolix is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist, the trial assessed the treatment in 535 women.
Insulin Glargine 300 U/mL Effective in Pediatric Patients With T1D
Insulin glargine 300 U/mL was found to be comparable to insulin glargine 100 U/mL in providing effective glycemic control in pediatric patients with type 1 diabetes.
New Treatment Approved for Osteoporosis
The Company is currently conducting a comparative study with the aim of having the treatment designated as a therapeutic equivalent to Forteo.
Burosumab Approved to Treat X-Linked Hypophosphatemia in Patients as Young as 6 Months
The FDA has expanded the approval of Crysvita (burosumab; Ultragenyx and Kyowa Kirin) to include treatment in pediatric patients as young as 6 months with X-linked hypophosphatemia.
Tramadol and Methadone Linked to Risk for Hypoglycemia in Patients With, Without Diabetes
Patients taking the analgesic tramadol have an increased propensity for hypoglycemia compared to other opioids, according to a new analysis of the Food and Drug Administration’s Adverse Event Reporting Systems.
Dapagliflozin Receives Fast Track Designation for Chronic Kidney Disease
The FDA has granted Fast Track designation to dapagliflozin (Farxiga; AstraZeneca) as a possible treatment to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease.
FDA Approves HbA1c Monitoring Device With Discreet Blood Sample Collection
The FDA has granted 510(k) market clearance to the OneDraw A1C Test system, which monitors HbA1c levels in individuals with diabetes for long-term glucose control.
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