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US FDA approves Bydureon BCise by AstraZeneca for type-2 diabetes biospectrumasia
October 24, 2017
It is an improved device provides significant HbA1c reduction with added benefit of weight loss
Merck brings customers closer to gene therapy product commercialization worldpharmanews
October 20, 2017
Merck today announced that its Carlsbad, California-based manufacturing facility for the production of BioReliance® viral and gene therapy products has completed both a U.S FDA Pre-License inspection and a European Medicines Agency (EMA) Marketing Authori
FDA approves Yescarta to treat adults with B-cell lymphoma europeanpharmaceuticalreview
October 20, 2017
The FDA has approved Yescarta, a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma…
FDA Approves Second CAR-T Cell Therapy and first for certain types of NHL americanpharmaceuticacreview
October 20, 2017
has become the second gene therapy to be approved by the US Food and Drug Administration, offering a new treatment approach for patients with certain types of large B-cell lymphoma.
AstraZeneca's Lynparza ups the ante at the PARP table with FDA's speedy breast cancer review fiercepharma
October 19, 2017
The agency Wednesday accepted the British drugmaker’s approval application and granted the medication its “priority review” tag.
FDA clears OptiScan’s automated bedside glucose monitoring system fiercebiotech
October 19, 2017
The OptiScanner 5000, which already has a CE mark, may now be used in surgical intensive care units (SICUs) to monitor plasma glucose levels and dysglycemia in patients, the company said in a statement.
FDA grants priority review for Exelixis’ Cabometyx to treat advanced RCC pharmaceufical-technology
October 19, 2017
Cabometyx is the tablet formulation of cabozantinib available in 20mg, 40mg or 60mg doses and its targets include MET, AXL and VEGFR-1, -2 and -3.
FDA accepts regulatory submission for Lynparza in metastatic breast cancer europeanpharmaceuticalreview
October 19, 2017
Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer…
FDA Approves IND of AmnioFix americanpharmaceuticacreview
October 18, 2017
MiMedx Group announced the company has been notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) Phase 2B clinical study for osteoarthritis of the knee may proceed.
FDA accepts Bristol-Myers Squibb's application for Opdivo (nivolumab) in patients with resected high worldpharmanews
October 18, 2017
FDA has accepted for priority review its supplemental Biologics License Application for Opdivo to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

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