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FDA approves new antibacterial drug europeanpharmaceuticalreview
August 31, 2017
The FDA has approved Vabomere for adults with complicated urinary tract infections…
FDA Approves New Antibacterial Drug pharmaceutical-technology
August 31, 2017
The U.S. Food and Drug Administration approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria.
FDA Approves First U.S. Treatment for Chagas Disease pharmaceutical-technology
August 31, 2017
The U.S. Food and Drug Administration granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.
FDA Accepts Pegvaliase BLA, Grants Priority Review Designation pharmaceutical-technology
August 31, 2017
BioMarin announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe)
Boehringer Ingelheim Receives FDA Approval for Cyltezo americanpharmaceuticalreview
August 31, 2017
Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases
FDA approves AstraZeneca’s faslodex for expanded use in breast cancer pharmaceutical-technology
August 31, 2017
AstraZeneca’s faslodex (fulvestrant) at 500mg has received approval from the US Food and Drug Administration (FDA) as monotherapy for expanded use in women with advanced breast cancer.
FDA Anounces GDUFA Rates for fiscal year 2018 contractpharma
August 30, 2017
FDA has announced fiscal year 2018 rates under GDUFA for contract manufacturing organization facilities.
FDA targets rogue clinic using Sanofi's smallpox vaccine in unapproved cancer therapy fiercepharma
August 30, 2017
FDA head Scott Gottlieb pledges more oversight on stem cell practices as the agency found unregulated use of a smallpox vaccine in a stem cell concoction for cancer patients.
FDA accepts Genentech’s sBLA for gazyva to treat untreated follicular lymphoma pharmaceutical-technology
August 30, 2017
The US Food and Drug Administration (FDA) has accepted biotechnology company Genentech’s supplemental biologics licence application (sBLA) and granted priority review for gazyva (obinutuzumab) for the treatment of untreated follicular lymphoma.
FDA Grants Breakthrough Therapy Designation to DS-8201 americanpharmaceuticalreview
August 30, 2017
FDA has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), for the treatment of patients with HER2-positive

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