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FDA agrees to review Merck and Pfizer’s sBLA for Bavencio and Inlyta pharmaceutical-technology
February 13, 2019
The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) submitted by Merck subsidiary EMD Serono and Pfizer for a Bavencio (avelumab) and Inlyta (axitinib) combination to .....
FDA Approves Eylea Injection sBLA americanpharmaceuticalreview
August 20, 2018
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumt biospace
March 15, 2018
Merz North America announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA)
FDA Accepts sBLA for Prolia in Glucocorticoid-Induced Osteoporosis americanpharmaceuticacreview
October 11, 2017
Glucocorticoid medications, which are used to treat many inflammatory conditions, can cause significant side effects, including bone loss.