Latest Biotech News

The FDA granted accelerated approval to AstraZeneca’s oral SERD camizestrant (Camizestrant) combined with a CDK4/6 inhibitor for patients with emergent ESR1-mutated HR+, HER2– advanced breast...

Rezubio Pharmaceuticals advanced RZ-520 into Phase I after IND clearance by both the FDA and China’s NMPA, with dosing beginning in healthy volunteers for chronic respiratory diseases. The...

Beam Therapeutics shared additional data from its Phase 1/2 program of a gene editing candidate for alpha-1 antitrypsin deficiency at the ERS meeting, reporting outcomes after one year in six...

Superluminal Medicines raised an oversubscribed $60 million Series B to accelerate its AI-powered GPCR platform and move its lead selective, biased MC4R agonist into clinical testing by year-end....

Novo Nordisk ended two additional late-stage cardiovascular outcomes trials for ziltivekimab, an IL-6 inhibitor, after a data monitoring committee concluded the studies were unlikely to succeed....

INTerpath-001 results highlighted a clinically meaningful improvement when the bespoke intismeran mRNA-LNP therapy is added to pembrolizumab in cutaneous melanoma. Reporting characterizes the...

Novartis said its del-desiran Phase 3 Harbor trial missed a crucial primary endpoint, dealing another blow to the asset acquired in Avidity Biosciences’ $12 billion takeover. The failure adds to a...

A retrospective University of Colorado Hospital analysis suggests a weekly cladribine plus rituximab approach may outperform a standard daily cladribine schedule in hairy cell leukemia. The small...

Rezubio’s RZ-520 IND clearance and Acepodia’s ACE-723 IND clearance together expand early clinical activity across respiratory and liver cancer programs. Both updates include readiness to dose in...

FDA has granted accelerated approval for AstraZeneca’s oral SERD camizestrant in a defined population of ESR1-mutated HR+, HER2– advanced breast cancer, despite a negative vote from the agency’s...

Novo Nordisk has stopped two late-stage cardiovascular outcomes trials of ziltivekimab, including the HERMES and ATHENA studies, after an independent data monitoring committee concluded the...

Merck and Moderna reported positive Phase III results from INTerpath-001 for intismeran (mRNA-4157/V940), their bespoke AI-designed mRNA therapeutic, when combined with pembrolizumab (Keytruda) in...

Novartis said pelacarsen failed to achieve its intended benefit in a Phase 3 cardiovascular outcomes study, raising stakes for other inflammation-targeting and lipid-adjacent programs. The Swiss...

Superluminal Medicines raised a $60 million oversubscribed Series B to advance its AI-powered GPCR platform and move its first clinical program into Phase I by year-end. The lead candidate is a...

Rezubio Pharmaceuticals advanced RZ-520 into Phase I after receiving IND clearances from both the FDA and China’s National Medical Products Administration (NMPA). The company says dosing is...

Acepodia said it received FDA IND clearance for ACE-723, a GPC3-targeted dual-payload antibody-drug conjugate. The company plans to begin a Phase I study in patients with unresectable or...

GSK agreed to pay $110 million for a Phase 1-ready Hutchmed asset in a new class of cancer drugs based on antibody-targeted therapy conjugates (ATTCs). The deal gives GSK rights to the first...

A new study describes a CAR T approach aimed at fusion-driven solid tumors using GPNMB as the target antigen. The research extends the CAR T playbook beyond hematologic malignancies by focusing on...

Researchers reported that dendritic cell SHP1 acts as a molecular brake limiting the development of long-lived, memory-like CD8 T cells via TCF-1/Wnt signaling. The study, published in Medical and...

FDA granted AstraZeneca an accelerated approval for camizestrant (an oral selective estrogen receptor degrader, or SERD) in certain breast cancer patients, despite a negative advisory committee...