AllSci News
CHMP recommends Gilead's Trodelvy plus Keytruda for PD-L1-positive mTNBC
Sacituzumab govitecan (Trodelvy) in combination with pembrolizumab (Keytruda) has received a CHMP positive opinion for first-line treatment of...
CHMP recommends EU approval of Roche's Susvimo for nAMD
Roche (SWX: ROG) has secured a positive CHMP recommendation for Susvimo (ranibizumab injection) 100 mg/mL for neovascular age-related macular degeneration,...
CHMP backs leriglitazone for early-stage cerebral adrenoleukodystrophy in children
Leriglitazone (NEZGLYAL) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, positioning it...
Ultomiris misses Phase III endpoint in adult HSCT-TMA, leaving pediatric approval path intact
AstraZeneca (LSE/STO/NYSE: AZN) reported that ravulizumab (Ultomiris) failed to meet the primary endpoint in a Phase III placebo-controlled trial in adults...
Argenx acquires Forte for USD 2.2b to add first-in-class CD122 antibody to immunology pipeline
Netherlands-based argenx (Euronext & Nasdaq: ARGX) has agreed to acquire Dallas-based Forte Biosciences, Inc. (Nasdaq: FBRX) for USD 77 per share in cash,...
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...
Icotyde gains CHMP backing as first oral IL-23 receptor antagonist for plaque psoriasis
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Icotyde (icotrokinra) as a plaque psoriasis...
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...
Sanofi abandons amlitelimab in atopic dermatitis despite positive Phase III data
Sanofi (Nasdaq: SNY) announced on July 24, 2026 that it will not submit amlitelimab (SAR445229, KY1005), its OX40-ligand monoclonal antibody, for regulatory...
Amgen submits data to FDA challenging Tavneos withdrawal proposal in rare vasculitis
Amgen (Nasdaq: AMGN) submitted data and analyses to the US FDA on July 23, 2026, in support of its request for a formal hearing on Tavneos (avacopan), the...
AstraZeneca pulls Imfinzi EU expansion after CHMP questions benefit-risk in bladder cancer
AstraZeneca's bid to expand durvalumab (Imfinzi) into high-risk non-muscle invasive bladder cancer has ended in the EU after the European Medicines Agency...
Scribe Therapeutics raises USD 128.7 million in IPO priced at top of range
Scribe Therapeutics Inc. (Nasdaq: SCTX), a clinical-stage biotechnology company co-founded by Nobel laureate Jennifer Doudna, priced an upsized initial...
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...
NIH backs Mount Sinai's FSH-blocking antibody for Down syndrome Alzheimer's
Icahn School of Medicine at Mount Sinai has received a USD 1,210,250 NIH R01 grant to test whether blocking follicle-stimulating hormone (FSH) can reduce...
Phoenix Nest gets NIH backing for Sanfilippo syndrome gene therapy manufacturing
Phoenix Nest, a Brooklyn, New York-based biotechnology company, has received a USD 1.49 million NIH SBIR grant to fund manufacturing and analytical...
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