Development

Merck and Moderna report that the personalized mRNA plus mAb cancer therapy cleared its first phase 3 hurdle, cutting recurrence risk beyond pembrolizumab alone.

Webinar Date/Time: Tue, Sep 8, 2026 11:00 AM EDT

Australia's first commercial imlifidase transplant offers a path forward for patients whose antibodies had blocked a compatible kidney.

Genprex moves its diabetes gene therapy toward the clinic, tapping a CGMP CDMO after preclinical models reversed hyperglycemia in mice.

Outsourced cell and gene therapy manufacturing is set to grow nearly 6-fold by 2035 as biotech pipelines outpace in-house capacity.

The independent data monitoring committee's finding leaves clinicians without a new option for PD-L1-low NSCLC, a population historically underserved by current immunotherapies.

IASO Bio adds a fratricide-resistant CAR-T platform to its pipeline, aiming to speed novel T-cell malignancy therapies to patients.

Spevatamig's fast track status targets a cancer where 5-year survival is under 20%, pairing a novel mechanism with pembrolizumab.

Fresh $175 million in funding follows Silence's 88% response rate in its divesiran polycythemia vera trials, positioning the company for a planned 2027 phase 3 push.

Under the 5-year manufacturing deal, NurExone will access Made Scientific's Princeton, NJ, GMP facility to speed regenerative exosome therapies toward clinical trials.

AbCellera aims to tap public markets to push ABCL635 forward after the therapy cut menopause hot flash severity 58% versus 12% for placebo in trials.

Zamubafusp alfa's FDA fast track status highlights the therapy's ability to remove toxic amyloid already damaging the heart and kidneys in AL amyloidosis patients.

Silence's siRNA drug freed 88% of trial patients from ongoing phlebotomies, a chronic burden for people with polycythemia vera.

Early Parkinson patients could gain a first disease-modifying option as ACI-7104 clears a major FDA hurdle after strong interim results.

Akeso is pairing a next-gen bispecific ADC with its PD-1/VEGF antibody, ivonescimab, in a first-line push against hard-to-treat breast cancer.

AWS's AI and cloud tools aim to compress Novo Nordisk's path from drug target to first human dose for chronic disease patients.

BI-1808 plus pembrolizumab posted a 24% response rate in platinum-resistant ovarian cancer, tripling pembrolizumab's historical rate alone.

Melanoma patients who failed anti-PD-1 therapy gain a new option after Replimune's oncolytic virus clears FDA on its third try.

The facility aims to scale global biologics supply, supporting patient access to advanced therapies as manufacturing capacity becomes a bottleneck in drug delivery.

Mediar Therapeutics has signed a collaboration and option agreement with Ono Pharmaceutical to co-develop novel antibody therapeutics targeting myofibroblast biology in fibro-inflammatory diseases, building on Mediar's existing three-program antifibrotic antibody pipeline.

Backed by an 84.3% drop in RSV hospitalizations, Enflonsia could extend protection to high-risk infants still vulnerable in their second season.

Sanofi has suspended a phase 2 trial of SAR445399, an anti-IL-1R3 monoclonal antibody, in non-cystic fibrosis bronchiectasis, part of new ceo Belén Garijo's ongoing portfolio review rather than a safety concern.

Nonhealing wounds precede 80% of diabetes-related amputations, and BIOxHEAL is now cleared to test whether it can change that in a controlled trial.

Alteogen has licensed its ALT-B4 subcutaneous platform to an undisclosed global pharmaceutical company in a deal worth up to $365 million.

ConcertAI executives discussed how the company's integration of CancerLinQ has expanded the platform beyond quality reporting, using artificial intelligence to deliver faster clinical insights, improve trial matching, and support oncology practices with real-time data.