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Doravirine has been used in trials studying the treatment of HIV-1, HIV-1 Infection, Renal Impairment, and Human Immunodeficiency Virus (HIV) Infection. In particular, doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines [FDA Label, L4562]. Doravirine is subsequently available by itself or as a…
Eravacycline, known as _Xerava_ by Tetraphase Pharmaceuticals, is a fully synthetic fluorocycline antibiotic of the tetracycline class with activity against clinically significant gram-negative, gram-positive aerobic, and facultative bacteria. This includes most of those bacteria resistant to cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, multidrug-resistant strains, and carbap…
2018.8.23, The U.S. Food and Drug Administration today approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I and II hereditary angioedema (HAE). HAE is a rare and serious genetic disease that affects people with low levels of and poorly functioning C1-INH proteins in the body. This results in recurrent, unpredictable e…
August 22, 2018, The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).
“While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastati…
On August 20th, the US FDA announced the approval of Biocodex's Diacomit (stiripentol), which was used in combination with clobazam to treat seizures in patients with Dravet syndrome over 2 years of age. It is worth mentioning that this is also the 31st new drug approved by the US FDA.
Dravet syndrome is also known as Severe Myoclonic Epilepsy of infancy (SMEI). It is a rare refractory epilepsy s…
August 10, 2018, The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be responsive (“amenable”) to treatment with Galafold based on laboratory data. Fabry disease is a rare and serious genetic disease that re…
August 10, 2018, The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year. Annovera is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal s…
August 10, 2018, The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characteri…
August 8, 2018, The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifica…
Lusutrombopag is an orally bioavailable thrombopoietin receptor (TPOR) agonist developed by Shionogi & Company (Osaka, Japan). TPOR is a regulatory target site for endogenous thrombopoietin, which acts as a primary cytokine to promote megakaryocyte proliferation and differentiation, and affect other hematopoietic lineages as well, including erythroid, granulocytic and lymphoid lineages [A36736…
Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). The phosphate c…
On July 23, 2018, Abbott's key product, elagolix, was approved by the US Food and Drug Administration, which will be used to treat the pain caused by endometriosis and become the indication for more than 10 years. Come to the first new oral medication.
Elagolix will be sold under the trade name Orilissa and will be priced at $845 per month, which is an important step for Abbott as it marks the b…