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Latest Biotech News

Gene therapy regulatory risk

May 18, 2026

Regenxbio shares fell sharply after investors reacted to guidance that the FDA may require a randomized controlled trial for its DMD gene therapy candidate RGX-202, despite positive pivotal phase...

Nephrology pivotal data

May 18, 2026

Telitacicept, developed by RemeGen, showed a significant reduction in proteinuria in a prespecified interim analysis of a phase 3 trial in high-risk IgA nephropathy patients. In NEJM-published...

Biopharma dealmaking and capital allocation

May 18, 2026

JPMorgan’s Q1 2026 biopharma licensing and venture report shows dealmaking momentum alongside tighter risk tolerance, with licensing value rising even as venture funding for early-stage companies...

Oncology biomarker and treatment guidance

May 18, 2026

Researchers presenting at ESTRO 2026 reported a new approach to guide treatment in advanced cancer using circulating tumor DNA (ctDNA) detected in blood plasma. The work positions ctDNA as a...

Radiotherapy evidence – prostate

May 18, 2026

A study presented at ESTRO 2026 in Stockholm found that prostate cancer radiotherapy delivered in two larger doses over eight days was as safe and effective as a conventional five-fraction...

Radiotherapy evidence – metastatic breast cancer control

May 18, 2026

Researchers at ESTRO 2026 reported targeted stereotactic body radiotherapy (SBRT) data for oligometastatic breast cancer, indicating potential for extending control and progression-free survival...

AI in clinical workflows

May 18, 2026

An international clinical trial reported improved radiotherapy planning performance using AI for cervical and prostate cancer treatment, with investigators from University College London (UCL) and...

Biotech innovation in operations

May 18, 2026

Biotech and pharma teams are increasingly turning to strategic outsourcing to capture more value from mature products as patent cliffs loom and internal resources face pressure. An analysis...

Late-stage oncology failure in melanoma immunotherapy

May 18, 2026

Regeneron’s LAG-3 inhibitor missed its primary endpoint in a phase 3 melanoma trial, failing to beat Merck’s Keytruda in the study readout. Analysts cited the result as the second late-stage...

Regulatory pathway pressure for Duchenne gene therapy

May 18, 2026

Regenxbio’s RGX-202 generated positive pivotal phase 3 data for Duchenne muscular dystrophy, but investors reacted negatively after the FDA recommended the company run a randomized controlled...

Phase 3 progress in IgA nephropathy with BAFF/APRIL dual targeting

May 18, 2026

RemeGen’s telitacicept delivered a stronger reduction in proteinuria than placebo in a prespecified interim analysis of a phase 3 trial in high-risk IgA nephropathy. In patients with persistent...

New CTDNA blood approach showcased for oligometastatic treatment tailoring

May 18, 2026

Researchers presented an approach using circulating tumor DNA (ctDNA) detected in blood plasma to tailor radiotherapy and treatment decisions for patients with oligometastatic cancers. The...

AI-driven radiotherapy planning for cervical and prostate cancer

May 18, 2026

An international clinical trial led by University College London (UCL) and the London School of Hygiene & Tropical Medicine (LSHTM) reported that AI can improve radiotherapy treatment planning for...

Radiotherapy schedule de-escalation in prostate cancer

May 18, 2026

New findings presented at ESTRO 2026 in Stockholm reported that a prostate cancer radiotherapy regimen delivered in two larger sessions over eight days can be as safe and effective as the...

Targeted SBRT approach to control early metastatic breast cancer

May 18, 2026

Researchers at ESTRO 2026 presented evidence that targeted stereotactic body radiotherapy (SBRT) can extend control in early-stage breast cancer that has begun to spread, described as...

Oncology delivery tech: implantable ‘cell factories’ for biologics

May 18, 2026

Startup Durabilityte is positioning implantable engineered cell “factories” as a way to produce therapeutic proteins inside the body, aiming to bypass parts of conventional biologics...

Biopharma deals: licensing carries the ecosystem while early funding stays tight

May 18, 2026

JPMorgan’s Q1 2026 Biopharma Licensing and Venture report said licensing and M&A activity is accelerating, even as venture capital remains selective and risk-averse. The bank reported biopharma...

Molecular oncology mechanism: DKC1-linked sphingolipid disruption in colorectal cancer

May 18, 2026

A study in Nature Communications linked dyskerin pseudouridine synthase 1 (DKC1) to colorectal cancer progression, describing how the protein disrupts sphingolipid biosynthesis to support tumor...

Nephrology / IgA nephropathy clinical update

May 18, 2026

RemeGen’s telitacicept produced a large proteinuria reduction in a prespecified interim analysis of its Phase 3 TELIGAN program in high-risk IgA nephropathy, according to results published in...

Muscle disease / DMD gene therapy regulatory path and market impact

May 18, 2026

Regenxbio’s RGX-202 delivered positive pivotal Phase 3 data in Duchenne muscular dystrophy, but investors punished the stock after the company disclosed the FDA recommended a randomized controlled...