Feliza Mirasol

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.

Cellex Life CEO Dr Eric von Hofe and Professor of Immunology at Mayo Clinic, Dr Keith L. Knutson, explain why individualized tumor profiling, not off-the-shelf targeting, is key to effective personalized cancer vaccines.

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.

Not all regulatory milestones are equal, and the differences can determine how fast a therapy reaches patients. Read this guide to 4 key FDA and EU pathways.

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.

Dr Steve Harr, Sana Biotechnology's CEO, identifies scalability, commercialization, and reimbursement as the defining hurdles for curative islet cell therapy in type 1 diabetes.

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.

Dr Steve Harr of Sana Biotechnology describes how converging islet transplant science makes a single-treatment cure for type 1 diabetes without immunosuppression an inevitable outcome.

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

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

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.

Sana Biotechnology's CEO, Dr Steve Harr, weighs in on how CRISPR-edited donor islet cells have survived 14 months without immunosuppression in a type 1 diabetes patient.

Under the deal, Pathos gains ex-China rights and will fund development of the bispecific ADC, already in phase 3 testing for triple-negative breast cancer.

Oblenio Bio has dosed the first patients in a phase 1a trial of tri-specific T-cell engager LBL-051 for refractory autoimmune disease.

Rocket Pharmaceuticals has reported a positive safety update for RP-A501 from the first 3 patients treated under a modified phase 2 protocol in Danon disease.

FDA has granted fast track designation to Aravax's PVX108, a peptide immunotherapy for peanut allergy, ahead of phase 2 data.

Novo Nordisk's ziltivekimab failed to reduce cardiovascular events in the phase 3 ZEUS trial despite confirmed IL-6 target engagement.

The EC has approved AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan ADC for 1st-line metastatic TNBC, which showed a 5.0-month overall survival benefit over chemotherapy.

We answer readers’ top questions on limit of blank, limit of detection, limit of quantitation, acceptance criteria, and equivalence testing in analytical method validation.

Kelun-Biotech's sac-TMT has gained NMPA acceptance for a new first-line indication application in advanced triple-negative breast cancer.

Collaboration between suppliers and developers, as well as viral vector manufacturing simplification, are becoming critical to CGT's commercial future, says Brandon Pence of FUJIFILM Biosciences.