Tag «FDA»

FDA approves new antibacterial drug Vabomere (meropenem, vaborbactam)

It’s only fair to share… Meropenem Beta-lactamase inhibitor vaborbactam FDA approves new antibacterial drug 08/29/2017 The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits …

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

It’s only fair to share… FDA approves Intrarosa for postmenopausal women experiencing pain during sex The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing …

Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation

It’s only fair to share… ROCKVILLE, Md., Sept. 22, 2016 /PRNewswire/ — Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria® PfSPZ Vaccine.  Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction. According to the …

US FDA grants approval for Novartis’ Ilaris (canakinumab) to treat Periodic Fever Syndromes

It’s only fair to share… Ribbon diagram of canakinumab (blue) bound to IL-1β (yellow) from PDBentry 5bvp[1] US FDA grants approval for Novartis’ Ilaris to treat Periodic Fever Syndromes Novartis has received the US Food and Drug Administration’s (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions. 26 September 2016 Read at http://www.pharmaceutical-technology.com/news/newsus-fda-grants-approval-for-novartis-ilaris-to-treat-periodic-fever-syndromes-5014453?WT.mc_id=DN_News …

FDA approves Amjevita, a biosimilar to Humira

It’s only fair to share… FDA approves Amjevita, a biosimilar to Humira The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar toHumira (adalimumab) for multiple inflammatory diseases. Read more. FDA approves Amjevita, a biosimilar to Humira For Immediate Release September 23, 2016 Release The U.S. Food and Drug Administration today approved …