Tag «FDA»

FDA approves first PI3K inhibitor Piqray (alpelisib) for breast cancer

FDA approves first PI3K inhibitor for breast cancer syn https://newdrugapprovals.org/2018/06/25/alpelisib-byl-719/ Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as …

FDA approves CAR-T cell therapy Yescarta (Axicabtagene ciloleucel) to treat adults with certain types of large B-cell lymphoma

FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma Yescarta is the second gene therapy product approval in the U.S. The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not …

FDA approves new antibacterial drug Vabomere (meropenem, vaborbactam)

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 certain types of resistance mechanisms …

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

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 the active ingredient prasterone, which …

Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation

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 FDA, “Fast Track is a …

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

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 Novartis receives three FDA Breakthrough …

FDA approves Amjevita, a biosimilar to Humira

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 Amjevita (adalimumab-atto) as a biosimilar …