Category «FDA 2019»

FDA approves treatment Inrebic (fedratinib) for patients with rare bone marrow disorder

It’s only fair to share… FDA approves treatment Inrebic (fedratinib) for patients with rare bone marrow disorder Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. …

FDA approves third oncology drug Rozlytrek (entrectinib) that targets a key genetic driver of cancer, rather than a specific type of tumor

It’s only fair to share… FDA approves third oncology drug Rozlytrek (entrectinib) that targets a key genetic driver of cancer, rather than a specific type of tumor  FDA also approves drug for second indication in a type of lung cancer The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for …

FDA approves new antibiotic Xenleta (lefamulin) to treat community-acquired bacterial pneumonia

It’s only fair to share… FDA approves new antibiotic  Xenleta (lefamulin) to treat community-acquired bacterial pneumonia The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, M.D., …

Selinexor

It’s only fair to share…   Selinexor セリネクソル KPT-330 UNII-31TZ62FO8F (Z)-3-[3-[3,5-bis(trifluoromethyl)phenyl]-1,2,4-triazol-1-yl]-N‘-pyrazin-2-ylprop-2-enehydrazide Formula C17H11F6N7O CAS 1393477-72-9 Mol weight 443.306 FDA, APPROVED 2019/7/3, Xpovio CAS : 1393477-72-9 (free base)   1421923-86-5 (E-isomer)   1621865-82-4 (E-isomer)   Unknown (HCl) Treatment of cancer, Antineoplastic, Nuclear export inhibitor Selinexor (INN, trade name Xpovio; codenamed KPT-330) is a selective inhibitor of nuclear export used as an anti-cancer drug. It works by quasi-irreversibly binding to exportin …

FDA approves new treatment Vyleesi (Bremelanotide) for hypoactive sexual desire disorder in premenopausal women

It’s only fair to share…   Bremelanotide SYNTHESIS……. https://newdrugapprovals.org/2015/02/18/palatins-bremelanotide-under-clinical-trials-female-libido-enhancer/ The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. “There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic …

FDA approves new treatment Victoza (liraglutide) for pediatric patients with type 2 diabetes

It’s only fair to share…     The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. …

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

It’s only fair to share… The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections …

Onasemnogene abeparvovec オナセムノジーンアベパルボベック

It’s only fair to share…   Onasemnogene abeparvovec オナセムノジーンアベパルボベック DNA (synthetic adeno-associated virus 9 vector scAAV9.CB.hSMN human survivor motor neuron protein-specifying) Zolgensma FDA 2019/5/24 APPROVED CAS: 1922968-73-7 AVXS-101 Spinal muscular atrophy treatment Treatment of Spinal Muscular Atrophy (SMA) Type 1 Gene therapy product Onasemnogene abeparvovec, sold under the trade name Zolgensma, is a gene therapy medication used to treat spinal muscular atrophy (SMA). …

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

It’s only fair to share… 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 …

FDA approves first treatment Ruzurgi (amifampridine) for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

It’s only fair to share… FDA approves first treatment Ruzurgi (amifampridine)  for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA …