Keeping Track: FDA Approves First Rx DHEA, Receives Applications For Midostaurin, Gesulkumab, Biosimilar Avastin
The latest drug development news and highlights from our FDA Performance Tracker.
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Proof Suggested For DHEA Improving Pre-Menopausal Women's Sex Drive
"We've identified the patient population that would benefit from this," said Vitaly Kushnir, of the Center for Human Reproduction. Fertility Nutraceuticals-backed study shows subjects' Female Sexual Function Index scores increased by 17% for desire, 12% for arousal and 8% for lubrication.
Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel
Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.
Keeping Track: Cardio, Antibiotic Approvals Put FDA Over Last Year's Novel Drug Count
The latest drug development news and US FDA highlights from our Performance Tracker.