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FDA links intragastric balloons to 5 more deaths, bringing total to 12 since 2016 pharmafile
June 07, 2018
Five more deaths have been reported to the FDA in patients using intragastric balloon systems, meaning that 12 total deaths have been linked to the use of the devices since 2016.
FDA approves Pfizer's Xeljanz for ulcerative colitis pharmatimes
June 06, 2018
The FDA has approved Pfizer's Xeljanz (tofacitinib) for the treatment of moderately to severely active ulcerative colitis.
FDA approves novel preventive treatment for migraine worldpharmanews
June 05, 2018
The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults.
FDA takes new steps to advance digital health, opening docket to solicit feedback on software products worldpharmanews
June 05, 2018
Today, the FDA is opening a docket to solicit feedback on important provisions of the 21st Century Cures Act ("Cures Act").
FDA halts CRISPR and Vertex’s upcoming gene editing trial biospectrumasia
June 04, 2018
The companies sought approval in April to begin the early-stage study in humans; it would be one of the first in the U.S. involving gene editing, a method of cutting out and replacing disease-causing snippets of DNA.
Pfizer's Xalkori receives FDA breakthrough therapy designation biospectrumasia
June 01, 2018
If approved in patients with metastatic NSCLC with MET exon 14 alterations, XALKORI will be the only TKI with demonstrated efficacy in three separate biomarker-driven indications in NSCLC.
FDA approves BioMarin’s enzyme substitution therapy to treat PKU pharmaceutical-technology
June 01, 2018
The US Food and Drug Administration (FDA) has approved pharmaceutical company Biomarin’s Palynziq to treat phenylketonuria (PKU).
FDA grants priority review to Astellas’ NDA for gilteritinib pharmaceutical-technology
June 01, 2018
The US Food and Drug Administration (FDA) has accepted Astellas Pharma’s new drug application (NDA) for gilteritinib and granted priority review for the product’s use in the treatment of acute myeloid leukaemia (AML).
FDA accepts new drug application for Novartis’ Promacta pharmaceutical-technology
June 01, 2018
The FDA’s award of a priority review is based on Novartis’ study in which 52% of treatment-naïve SAA patients achieved complete response at six months when treated with Promacta and standard IST.
FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes drugs
May 31, 2018
The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabete

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