Latest Biotech News

AstraZeneca scrapped multiple late-stage pipeline programs after disappointing efficacy, including shutting down atuliflapon, a FLAP inhibitor tested in a phase 2 asthma study. The company said it...

CareDx agreed to acquire Naveris for up to $260 million, extending its precision oncology footprint with viral-driven liquid biopsy monitoring. The acquisition targets NavDx, a test designed to...

GeneMind Biosciences said China’s NMPA registered its SURFSeq 5000 Dx high-throughput sequencer as a Category III medical device. With registration, the company can deploy the diagnostic version...

Enterobiotix raised £19 million (about $25.7 million) to fund phase IIb development of its microbiome-based therapy for IBS-C. The company’s lead program, EBX-102-02, targets irritable bowel...

South Korea’s MFDS cleared Curocell’s Limcato (anbalcabtagene-autoleucel; anbal-cel) as the first homegrown CAR T therapy for advanced diffuse large B-cell lymphoma. The approval marks a domestic...

Suvoda launched an updated agentic AI-powered system for randomization and trial supply management (RTSM), aiming to accelerate study startup and reduce manual workload for sponsors. The company...

Mount Sinai researchers reported that detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma models. Published in Nature Biotechnology, the work...

Boehringer Ingelheim reported phase 3 results for survodutide, a dual-acting obesity shot licensed from Zealand Pharma. In the Synchronize-1 trial, the company said participants on survodutide...

The FDA moved to shrink clinical trial reporting lags by launching a pilot approach to review data in real time as it is accrued. The agency said it will start with oncology studies run by...

The FDA is set to convene an oncology advisory committee meeting after a long hiatus, with AstraZeneca drugs among the primary topics. The agenda centers on applications spanning HR+/HER2- locally...

The FDA proposed withdrawing Amgen’s Tavneos, alleging “untrue statements of material fact” in the approval application for avacopan. The action would target a C5aR antagonist approved in 2021...

Chiesi agreed to buy KalVista Pharmaceuticals for about $1.9 billion, adding Ekterly (sebetralstat) to its rare-disease portfolio. Ekterly is the first FDA-approved oral on-demand treatment for...

South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell’s Limcato (anbalcabtagene-autoleucel; anbal-cel), marking the first MFDS-cleared homegrown CAR T therapy. The treatment is...

Mount Sinai researchers reported a design principle for mRNA vaccine potency: detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in a lymphoma model. The work,...

Insilico Medicine said it advanced its AI drug target discovery framework by integrating Target Identification Pro (TargetPro) with Target Identification Benchmark (TargetBench 1.0) into a...

GeneMind Biosciences received NMPA registration for its SURFSeq 5000 Dx high-throughput sequencer as a Category III medical device in China. The registration allows deployment for DNA and RNA...

Mayo Clinic researchers validated an AI model that can detect pancreatic cancer up to three years before diagnosis using routine abdominal CT scans. The approach, described as identifying subtle...

Enterobiotix raised about £19 million (US$25.7 million) to fund phase IIb development of EBX-102-02, a microbiome-based pill for irritable bowel syndrome with constipation (IBS-C). The company...

The FDA has launched a real-time review pilot aimed at making clinical-trial oversight faster and more data-driven, starting with oncology studies conducted by AstraZeneca and Amgen. The agency...

Chiesi has agreed to acquire KalVista Therapeutics in a $1.9 billion deal that adds an approved oral therapy for hereditary angioedema to its rare-disease portfolio. Analysts cited the transaction...