sBLA
FDA accepts Eisai’s Leqembi sBLA for early AD treatment
June 11, 2024Medical Communications Alzheimer's, Biogen, FDA, Neurology, sBLA
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted Eisai’s supplemental biologics license application …
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
April 24, 2024Medical Communications FDA, GSK, Oncology, endometrial cancer, sBLA
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for …
FDA accepts UCB’s sBLA for Bimzelx
April 5, 2024Medical Communications Bimzelx, FDA, Pharmacy, UCB, sBLA
UCB has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application …
argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment
February 20, 2024Medical Communications CIDP, FDA, Neurology, Vyvgart Hytrulo, argenx, sBLA
argenx has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for …
AstraZeneca’s sBLA for FluMist Quadrivalent accepted by FDA
October 24, 2023Medical Communications AstraZeneca, FDA, FluMist, Immunology, flu vaccine, sBLA
AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Agreement …
Arzerra approved by US FDA for leukaemia
January 20, 2016Research and Development, Sales and Marketing Afrezza, CLL, FDA, Genmab, Novartis, chronic lymphocytic leukaemia, ofatumumab, sBLA, supplementary biologics license application
The FDA has signed-off a supplemental Biologics License Application (sBLA), meaning Arzerra is approved for extended treatment of patients who …
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FibroFind appoints Lee Borthwick as CEO
