Policy & Regulation
Delcath publishes Phase 3 FOCUS subgroup data supporting HEPZATO in metastatic uveal melanoma
31 December 2025 - Oncology company Delcath Systems Inc (Nasdaq: DCTH) disclosed on Wednesday that it has published subgroup analyses from its phase 3 FOCUS study evaluating the Melphalan/Hepatic Deli...
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...
Mabwell reports first patient dosed in Phase II clinical trial of anti-IL-11 monoclonal antibody for pathological scarring
31 December 2025 - Chinese biopharmaceutical company Mabwell (SH:688062) announced on Tuesday that the first patient has been dosed in the Phase II clinical trial of its self-developed innovative anti...
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...
HUTCHMED savolitinib NDA for MET-amplified gastric cancer accepted for priority review in China
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SOFIE Biosciences reports first patient dosed Phase 3 clinical trial of [18F]FAPI-74
30 December 2025 - SOFIE Biosciences, a US manufacturer and developer of radiopharmaceuticals, announced on Monday that the first patient has been dosed in one of its two Phase 3 clinical trials evalu...