Latest Biotech News

Novartis announced plans to establish a flagship manufacturing hub in North Carolina as part of a $23 billion U.S. infrastructure investment, adding biologics, sterile packaging, and solid‑dose...

The U.K. research funding agency ARIA named a former DARPA official, Fisher, as its new chief, according to BioCentury reporting. The appointment signals ARIA’s continued strategy of importing...

France‑based Ocean Diagnostics completed a pilot clinical evaluation showing its rapid sequencing–based blood test matched gold‑standard blood cultures at 100% concordance and detected additional...

Taiho Pharmaceutical and Cullinan Therapeutics initiated a rolling NDA submission to the U.S. FDA for zipalertinib, seeking accelerated approval for patients with locally advanced or metastatic...

Researchers published a thermally programmed one‑pot CRISPR assay that integrates thermal control with CRISPR molecular recognition to deliver rapid, sensitive viral detection suitable for on‑site...

Sydnexis received a complete response letter (CRL) from the FDA that prompted industry commentary about regulatory transparency and shifting review expectations, BioCentury reported. The company’s...

Ginkgo Bioworks’ Datapoints unit announced the Virtual Cell Pharmacology Initiative (VCPI), a community-driven open-source effort to standardize virtual cell modeling for drug discovery. Ginkgo...

France-based Ocean Diagnostics reported a pilot clinical evaluation showing its rapid bloodstream-infection test matched conventional blood cultures at 100% in a 110-patient ICU study at Bordeaux...

Eli Lilly became the first pharmaceutical company to reach a $1 trillion market valuation, driven largely by demand for its obesity medicines and strong commercial performance across its...

A BioCentury report on Sydnexis’ complete response letter (CRL) has reignited criticism about the FDA’s transparency and shifting review standards, and hundreds of biotech leaders have sent a...

Novartis unveiled plans to build a flagship North Carolina manufacturing hub with end-to-end biologics, sterile packaging and solid-dose capabilities, part of a $23 billion U.S. infrastructure...

Resalis Therapeutics presented preclinical and translational data at TIDES Europe showing an antisense oligonucleotide (ASO) targeting miR-22 that the company says drives durable, metabolically...

Taiho Pharmaceutical and Cullinan Therapeutics began a rolling NDA submission to the FDA for zipalertinib, a targeted agent for locally advanced or metastatic NSCLC with EGFR exon 20 insertion...

Researchers published a thermally programmed one‑pot CRISPR assay in Nature Communications that integrates thermal control with CRISPR molecular recognition to deliver rapid, sensitive on-site...

Contineum Therapeutics reported top-line results from its Vista phase II trial of PIPE-307, an M1 receptor agonist developed with Janssen, showing the study missed primary and secondary efficacy...

GE Healthcare agreed to acquire Intelerad Medical Systems for $2.3 billion in cash to expand digital and cloud-enabled imaging capabilities for cardiology and radiology across outpatient and...

Eli Lilly briefly reached a $1 trillion market valuation intraday, becoming the first pharmaceutical company to hit the trillion-dollar mark. The surge was driven by blockbuster sales of its...

Ginkgo Bioworks announced the Virtual Cell Pharmacology Initiative (VCPI) through Ginkgo Datapoints, committing to build a standardized, community-driven dataset to accelerate virtual cell models...

France‑based startup Ocean Diagnostics reported a pilot clinical evaluation in which its rapid bloodstream pathogen ID test matched conventional blood cultures at 100% and strongly correlated with...

Resalis Therapeutics presented preclinical data at TIDES Europe on an antisense oligonucleotide (ASO) targeting miR‑22, which the company says drives metabolic reprogramming and sustained weight...