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sBLA

Showing 6 posts of 6 posts found.

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FDA accepts Eisai’s Leqembi sBLA for early AD treatment

June 11, 2024
Medical 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 …

News

GSK’s Jemperli accepted for FDA review for endometrial cancer treatment

April 24, 2024
Medical 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 …

News

FDA accepts UCB’s sBLA for Bimzelx

April 5, 2024
Medical 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 …

News

argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment

February 20, 2024
Medical 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 …

News

AstraZeneca’s sBLA for FluMist Quadrivalent accepted by FDA

October 24, 2023
Medical 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 …

News
Arzerra

Arzerra approved by US FDA for leukaemia

January 20, 2016
Research 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 …

News
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