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Regulatory decisions in oncology and advanced therapy
On July 30, the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) issued a favorable 10–3 determination that Replimune’s IGNYTE data for vusolimogene oderparepvec (RP1) in...
FDA review outcomes and effectiveness evidence in cell therapy
Capricor Therapeutics’ resubmitted biologics license application for Deramiocel took another hit after the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recommended against...
FDA approval expands radioligand therapy earlier in prostate cancer care
The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC)....
Clinical failure in late-stage cardiovascular inflammation strategy
Novo Nordisk’s IL-6 inhibitor ziltivekimab failed to reduce major cardiovascular events in the late-stage ZEUS trial, sending shares down nearly 9% in Friday trading. The Phase 3 study did not...
Regulatory pathway use in cancer approvals draws new scrutiny
Researchers published in JAMA raised concerns about how the US FDA is using accelerated approval in oncology, arguing that the pathway is being underutilized even as evidence standards appear to...
Blood-based biomarkers expand Alzheimer’s diagnostic access
A FDA-cleared blood test for Alzheimer’s disease assessment is gaining coverage as researchers highlight how blood-based biomarker (BBM) strategies can streamline amyloid pathology detection. The...
Oral drug development in sleep apnea backed by IPO funding
Apnimed raised $192 million in an initial public offering to fund what it positions as potentially the first oral drug for obstructive sleep apnea. The company plans to apply proceeds to Oxnimbi,...
Mega-deal talks raise consolidation stakes for big pharma
Reports indicate AstraZeneca is in talks with Bristol Myers Squibb about a merger that could be among the largest in pharma history, potentially creating an enlarged company spanning multiple key...
Artificial intelligence tools for clinical risk from wearable sleep data
Researchers unveiled a foundation model aimed at turning sleep signals into an early-warning system for health risks and clinical outcomes. The approach focuses on learning from measurable...
AI benchmarking platform for drug discovery and evaluation
Insilico Medicine launched what it describes as a benchmark-as-a-service to test whether frontier AI models make meaningful decisions in drug discovery beyond memorizing training data. The new...
Regulatory decisions for oncology cell and gene therapies
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) backed Replimune’s oncolytic virus program for an accelerated-approval bid in unresectable advanced cutaneous melanoma....
FDA approval expands radioligand therapy earlier in prostate cancer
The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC),...
Cell therapy effectiveness questioned by FDA advisory committee
Capricor Therapeutics faced a renewed setback for its Duchenne muscular dystrophy cardiomyopathy program as the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recommended against...
Cardiometabolic drug failure in Phase 3
Novo Nordisk’s IL-6 inhibitor ziltivekimab missed its primary clinical objective in the late-stage ZEUS trial, failing to reduce cardiovascular events in a population spanning atherosclerotic...
AI in healthcare operations and clinical decision workflows
Researchers at KAIST introduced RL-SPH, an AI system designed to produce feasible delivery, production, and workforce schedules that must satisfy multiple operational constraints at once. The...
Alzheimer’s diagnostics: blood test cleared by FDA
The FDA cleared Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio blood test, aiming to expand access to amyloid pathology assessment for earlier decision-making in Alzheimer’s disease....
Oncology regulation and evidence quality: accelerated approval use under scrutiny
A JAMA study reported concerns about how the FDA is using oncology regulatory pathways, arguing that accelerated-approval protections are being underutilized for confirmatory benefit and safety...
Biopharma M&A speculation
A report said AstraZeneca is in talks with Bristol Myers Squibb about a potential merger valued at about $400 billion, which would rank among the largest deals in the sector. The Financial Times...
New biotech listing capital for oral sleep apnea therapy
Apnimed raised $192 million in its IPO to fund regulatory and launch plans for Oxnimbi, a once-nightly oral candidate targeting obstructive sleep apnea. The company said it will apply proceeds to...
Drug discovery AI benchmarks in biotech R&D
Insilico Medicine launched a benchmark-as-a-service for AI drug discovery, positioning it as a way to test whether frontier models can make meaningful scientific decisions rather than simply...