Development
CHMP backs Lynavoy as first approved therapy for cholestatic pruritus in PBC
GlaxoSmithKline (GSK) received a CHMP positive opinion on 23 July 2026 recommending EU marketing authorisation for linerixibat (Lynavoy), making it the...
Positive Nature Medicine data emerge after Novartis halts development of first-in-class uveal melanoma ADC
Phase I data for DYP688, a first-in-class antibody-drug conjugate targeting metastatic uveal melanoma, demonstrated disease control in more than 80% of...
Ipsen's Phase III Bylvay failure extends long search for biliary atresia therapy
Ipsen (Euronext: IPN; ADR: IPSEY) reported on July 24 that the Phase III BOLD trial of odevixibat (Bylvay) in biliary atresia failed to meet its primary...
Genmab and AbbVie's epcoritamab fails survival endpoint in confirmatory DLBCL trial
Genmab and AbbVie clarified on July 23 that overall survival was the sole primary endpoint in the United States for the Phase III EPCORE DLBCL-1 trial...
Ipsen's Bylvay fails to improve native liver survival in biliary atresia Phase III trial
Ipsen's Phase III BOLD trial of Bylvay (odevixibat) in biliary atresia did not meet its primary endpoint of improving native liver survival versus placebo,...
Infinitopes debuts off-the-shelf esophageal cancer vaccine in clinic
Oxford, England-based Infinitopes has dosed the first patient in a trial testing whether a therapeutic cancer vaccine given before surgery can lower...
J&J's Tecvayli + Talvey combo cuts progression risk 89% in earlier-line relapsed myeloma
Johnson & Johnson (NYSE: JNJ) reported that its combination of two bispecific T-cell engagers reduced the risk of disease progression or death by 89% in...
Lilly completes retatrutide Phase III package ahead of planned Q1 2027 FDA filing
Eli Lilly and Company (NYSE: LLY) reported positive topline results from two additional Phase III trials of retatrutide, pushing the investigational triple...
Western survival data converge with overall HARMONi results for ivonescimab
Miami-based Summit Therapeutics Inc. (Nasdaq: SMMT) reported updated overall survival data from its global Phase III HARMONi trial showing that the hazard...
Arrowhead challenges Ionis in severe hypertriglyceridemia with positive Phase III plozasiran data
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) reported topline results from two pivotal Phase III trials of plozasiran in severe hypertriglyceridemia, data...
NanoViricides seeks to test oral antiviral against Bundibugyo Ebola in DRC
Shelton, Connecticut-based NanoViricides, Inc. (NYSE American: NNVC) has applied to the Democratic Republic of Congo's regulatory agency, ACOREP, for...
Radiopharm repurposes PD-L1 as a radiotherapy target after immunotherapy failure
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX), headquartered in Sydney, Australia and Malvern, Pennsylvania, reported updated data from the ongoing...
Agios narrows PK activator pipeline, dropping tebapivat in favor of mitapivat
Agios Pharmaceuticals (Cambridge, Massachusetts) (Nasdaq: AGIO) reported topline results from a Phase II trial of tebapivat, an oral pyruvate kinase...
Alpha DaRT shows early signs of boosting pembrolizumab responses in head and neck cancer
Alpha Tau Medical Ltd. (Jerusalem, Israel) (Nasdaq: DRTS, DRTSW) reported that Alpha DaRT, its intratumoral alpha-emitting radiotherapy device, produced a...
Imunon's IL-12 gene therapy shows early safety signal while reducing ovarian cancer residual disease
Imunon, Inc. (Lawrenceville, New Jersey; Nasdaq: IMNN) reported preliminary Phase II data for IMNN-001 in newly diagnosed advanced ovarian cancer, drawn...
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