Latest Biotech News

Celcuity secured U.S. FDA approval for Revtorpyk (gedatolisib) in HR+/HER2− locally advanced or metastatic breast cancer for patients without a PIK3CA mutation after progression on or following at...

AstraZeneca moved to lock in a stronger lung cancer strategy with a licensing deal for Dizal Pharmaceutical’s oral EGFR inhibitor Zegfrovy (sunvozertinib), a move tied to Phase 3 superiority data...

New data in Nature Communications suggests local complement component C3 can shape how tumors respond to checkpoint blockade. Researchers reported that C3’s impact is highly...

Biogen’s diranersen (BIIB-080) drew renewed attention at the Alzheimer’s Association International Conference after updated reporting on the Phase 2 Celia trial. Researchers described...

Cellares and Sonoma Biotherapeutics agreed to automate engineered Treg cell manufacturing for SBT-77-7101, an engineered regulatory T cell therapy now in Phase I development for poly-refractory...

Northeastern University research argued that AI can add predictive control to cell and gene therapy manufacturing—moving from reactive troubleshooting to batch-failure prediction, real-time...

Chai Discovery, an AI molecule-design company, secured a $400 million Series C round that triples its paper value from a prior financing, according to reports. The funding underscores how venture...

AdvanCell raised $315 million in a Series D to fund a lead prostate cancer radiopharmaceutical program and to support U.S. manufacturing capacity. The financing is aimed at advancing a Pluvicto...

Sapphiros won a $12.4 million award from HHS’s Biomedical Advanced Research and Development Authority (BARDA) to develop rapid molecular diagnostics for biothreats and emerging infectious...

A large U.S.-led cooperative group trial coordinated by Mayo Clinic found no survival benefit from extending lenalidomide maintenance beyond two years in standard-risk multiple myeloma. The...

Celcuity’s Revtorpyk (gedatolisib) cleared FDA approval for HR-positive/HER2-negative locally advanced or metastatic breast cancer in patients without a PIK3CA mutation after progression on...

AstraZeneca agreed to acquire exclusive global rights to Dizal Pharmaceutical’s oral EGFR exon 20 insertion drug Zegfrovy (sunvozertinib) in a deal worth up to $1.5 billion. AstraZeneca will pay...

A new analysis in Cell Death Discovery argues that cell therapy programs are repeatedly failing at IND and BLA/NDA gates due to technical and documentation mismatches rather than purely clinical...

At the Alzheimer’s Association International Conference, Biogen presented Phase II Celia data for diranersen (BIIB-080), a tau-lowering antisense oligonucleotide. Researchers reported clinical and...

AdvanCell raised a $315 million Series D to support development of a lead-based prostate cancer radiopharmaceutical and to expand or shore up U.S. manufacturing capacity. The financing is framed...

Johnson & Johnson announced plans to restructure its pharmaceutical manufacturing footprint, targeting exits from certain factories and reorganizing supply-chain operations. The company guided...

Qiagen’s QiaStat-Dx BCID GN Plus AMR Panel for bloodstream infection testing received CE-IVD certification, enabling routine clinical use in countries that recognize CE marking. The panel is...

A new research consortium under NHGRI funding is building a population genomic screening network to study real-world clinical implementation and outcomes. The initiative, called the Population...

Cellares and Sonoma Biotherapeutics agreed to automate the manufacturing of SonomaBio’s engineered regulatory T-cell therapy SBT-77-7101. The companies plan to translate SonomaBio’s manufacturing...

BIO warned that a proposed OMB rule governing federal financial assistance could destabilize the biomedical research ecosystem by shifting power away from peer review and adding at-will...