Food and Drug Administration (FDA)
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FGFR inhibitor gains FDA approval based on 40% response rate in MD Anderson-led Phase II trial
It is the first and only nasally-dosed glucagon, which is indicated for diabetic patients undergoing a severe drop in blood sugar. Previously it was only administered by a complicated injection system.
The FDA advisory committee canceled the meeting after Intra-Cellular provided the regulatory agency with additional data. No new meeting date has been scheduled.
FDA’s Sharpless Outlines Agency’s 4 Top Priorities: Tech, Hiring, Modernization and Increased Safety
In terms of modernizing frameworks, Sharpless focused on the agency’s efforts to approve generic drugs and biosimilars more quickly in order to lower drug prices. He also said the FDA needed to help the biopharma industry with “the most expensive part of drug discovery and development,” referring to clinical testing.
It is approved for adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
For LENVIMA plus KEYTRUDA Combination Treatment as Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment
In the pharmaceutical industry, continuous and secure data acquisition and documentation is crucial for production and storage requirements, and also for research and development.
Myxredlin is intended for use only in acute care settings under medical supervision.
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