Latest Biotech News

AstraZeneca and Bristol Myers Squibb are reportedly holding talks about a potential merger that could become one of the biggest deals in biopharma history, according to the Financial Times. A...

Replimune’s oncolytic virus therapy RP1 (vusolimogene oderparepvec) won a favorable vote from the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) for an accelerated approval...

FDA cleared lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), extending...

Novo Nordisk’s IL-6 inhibitor ziltivekimab failed in a late-stage cardiovascular outcomes study, with the company reporting negative results from the Phase 3 ZEUS trial. The drug did not reduce...

A new JAMA study raised concerns that accelerated approval in oncology is being underutilized, potentially weakening the evidentiary “safety net” that requires confirmatory trials after...

Insilico Medicine launched what it calls the first “Drug Discovery and Development Benchmark-as-a-Service” aimed at testing frontier AI models for decision-making rather than memorizing training...

A monthly recap of the GenomeWeb Top 40 showed life science tools and diagnostics stocks gaining more quickly than broader indices in July, with CareDx posting the largest gain. The roundup also...

A new prospective national study, CUP-COMP, is testing whether a blood-based molecular profiling approach can identify cancers of unknown primary by detecting molecular signals released by tumors...

The Alliance for Clinical Trials in Oncology activated the QUANTUM Trial (Alliance A062401), a new study opening bispecific immunotherapy evaluation in primary plasma cell leukemia, a rare and...

BIOCENTURY’s Emerging Company Profile Spot Bio describes a non-viral approach to deliver full-length genes to muscle using extracellular vesicles, with investigational work moving into...

FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) for adult patients with PSMA-positive metastatic hormone-sensitive prostate...

Replimune’s RP1 (vusolimogene oderparepvec) is bouncing back after an FDA advisory committee vote that supported the therapy despite negative briefing materials. The single-arm IGNYTE Phase I/II...

A randomized, double-blind, placebo-controlled trial in Nature Communications tested whether losartan and prednisolone could affect post-COVID syndrome and markers of cardiac inflammation. The...

Researchers reported that specially engineered extracellular vesicles reduced inflammatory damage and cytokine production in a mouse acute respiratory distress syndrome model. The work, from the...

A Johns Hopkins team validated an AI-powered blood test designed to detect liver cancer across two geographically and biologically distinct patient populations. The findings, published July 31 in...

FDA’s decision to move lutetium Lu 177 vipivotide tetraxetan into earlier metastatic hormone-sensitive prostate cancer settings is already triggering label-aligned diagnostic work around PSMA PET...

GenomOncology will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The goal is to translate long-read WGS...

Several sector-linked finance items highlighted activity across biotech-adjacent health tech and broader biopharma capital markets. Health tech funding rounds were reported as a cluster of July...

Insilico Medicine launched a Drug Discovery and Development Benchmark as a Service aimed at stress-testing frontier AI models on real-world scientific decision-making. The company described a...

Biotech execution also featured tools aimed at accelerating clinical trial operations and scaling trial-ready data pipelines. An acquisition story highlighted Grove AI’s voice-agent approach to...