PubChem

Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties.[A37348] The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies.[A40254] Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009,[A40250] in Canada on December 7, 2011 and by the FDA on December 17, 2018.[L4880]

November 28, 2018, The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. The LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, Inc., is used to detect the FLT3 mutation in patients with AML.

November 28, 2018, 

The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.

November 26, 2018, The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

November 16, 2018, The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

"Travelers' diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. 

On November 9, 2018, the FDA approved the new drug Yupelri (Revefenacin) for the treatment of patients with moderate to very severe chronic obstructive pulmonary disease.

On November 2, 2018, the US Food and Drug Administration approved lorlatinib (Lorbrena) to accelerate the approval of patients for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC), which have been used in one or more types of ALK cheese. Progression on tyrosine kinase inhibitors (TKIs).

On October 24, the US Food and Drug Administration (FDA) approved the launch of the new anti-influenza drug Xofluza (baloxavir marboxil), jointly developed by Japan’s Yanyeyi Pharmaceutical Co. and Roche, for the treatment of 12-year-old and above without complications. Acute flu patients. It is worth mentioning that this is the new anti-viral flu treatment method approved by the FDA for the first time in 20 years.

Talazoparib is a once-a-day oral poly ADP ribose polymerase (PARP) inhibitor. Preclinical studies have shown that talazoparib has a strong activity and has a dual mechanism of action, which can induce tumor cell death by blocking PARP enzyme activity and capturing PARP at the site of DNA damage. Talazoparib is currently being evaluated for advanced gBRCAm breast cancer, early triple-negative breast cancer, and DDR-deficient prostate cancer, and is used in combination with various immunotherapies for the treatment of solid tumors.

Elapegademase-lvlr is a novel enzyme replacement therapy for the treatment of adenosine deaminase deficiency in severe combined immunodeficiency (ADA-SCID) in children and adults. (ADA-SCID is an ultra-rare and highly destructive hereditary disease. Patients affected by ADA-SCID have an impaired immune system that prevents patients from fighting bacterial, viral and fungal infections.)