Research & Development
Samsung Bioepis begins direct commercialisation of BYOOVIZ in Europe
2 January 2026 - South Korean biopharmaceutical company Samsung Bioepis Co Ltd said on Friday that it has begun direct commercialisation of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across mult...
Corcept announces receipt of FDA Complete Response letter for relacorilant in hypercortisolism
31 December 2025 - Corcept Therapeutics Incorporated (NASDAQ: CORT) reported on Wednesday that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New D...
Axsome Therapeutics secures FDA priority review for AXS-05 in Alzheimer's disease agitation
31 December 2025 - New York-based biopharmaceutical company Axsome Therapeutics, Inc. (NASDAQ: AXSM) said on Wednesday that the US Food and Drug Administration has accepted for filing its supplemental...
Vanda's NEREUS approved by US FDA for prevention of motion sickness
31 December 2025 - Vanda Pharmaceuticals Inc (Nasdaq:VNDA), a US-based global biopharmaceutical company, announced on Tuesday that it has received approval from the US Food and Drug Administration (FD...
Diamyd Medical agrees accelerated efficacy readout in ongoing Phase 3 type 1 diabetes trial
30 December 2025 - Swedish biotechnology company Diamyd Medical AB (Nasdaq First North Growth Market:DMYD-B) said on Monday that it has reached alignment with the US Food and Drug Administration (FDA)...
INOVIO's INO-3107 Biologics License Application accepted by US FDA
30 December 2025 - Biotechnology company INOVIO (NASDAQ:INO) announced on Monday that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for INO-3107 for re...