by PEPID Newsroom | Jun 21, 2019 | Alerts
FDA approves bremelanotide (Vyleesi, AMAG Pharmaceuticals) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Bremelanotide is the first-in-class melanocortin 4 receptor agonist for HSDD, and joins Flibanserin as...
by PEPID Newsroom | Jun 4, 2019 | Alerts
Emgality (gacanezumab-gnlm) solution has been FDA approved for treatment of episodic cluster headache in adults, the first of its kind. Emgality was approved in 2018 to prevent migraines in adults, and now has shown to reduce the frequency of cluster headache attaches...
by PEPID Newsroom | Jun 4, 2019 | Alerts
The U.S. FDA approved a new indication for Zerbaxa (Ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABD/VABP) in patients 18 years and older. This approval addresses the threat of...
by PEPID Newsroom | May 24, 2019 | Alerts
Pigray (alpelisib) tablets have been FDA approved to treat breast cancer in combination with FDA-approved endocrine therapy fulvestrant. Pigray is approved for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...
by PEPID Newsroom | May 23, 2019 | Alerts, Pharmacy
Every year, the US FDA’s Center for Drug Evaluation and Research (CDER) releases a list of newly-approved novel drugs and therapeutic biological products. Last year’s Novel Drug Approvals list holds the record for the most number of approved drugs, effectively...
