Latest Biotech News

The U.S. Food and Drug Administration announced plans to hire more than 1,000 new staffers and launched a pilot program allowing sponsors to email quick clarifications to the Office of New Drugs...

GE Healthcare agreed to acquire medical imaging company Intelerad Medical Systems for $2.3 billion in cash, expanding GE’s footprint in cardiology and radiology software and cloud‑enabled imaging...

Taiho Pharmaceutical and Cullinan Therapeutics began filing a rolling NDA with the U.S. FDA for zipalertinib, their EGFR exon 20 insertion‑targeted therapy for locally advanced or metastatic...

Contineum Therapeutics reported top‑line results from its Phase II Vista study of PIPE‑307, an M1 receptor agonist for relapsing‑remitting multiple sclerosis, and the trial missed its primary and...

GSK’s Tesaro subsidiary and AnaptysBio have filed cross‑complaints in Delaware court over a decade‑old license for the cancer immunotherapy Jemperli. GSK asked the court to terminate the...

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

Eli Lilly became the first pharmaceutical company to reach a $1 trillion market valuation during intraday trading. The surge follows commercial success for the company’s obesity and diabetes...

Hundreds of biotech executives sent a letter to FDA Director Marty Makary urging regulatory predictability and warning that volatility threatens U.S. innovation. Signatories cited recent agency...

The FDA announced plans to hire more than 1,000 staffers and rolled out a pilot communications program that allows drug sponsors to submit short email clarifications to Office of New Drugs...

Novartis announced plans to build a flagship manufacturing hub in North Carolina as part of a $23 billion U.S. investment program. The project will add biologics, sterile packaging and solid-dose...

AstraZeneca said it will invest $2 billion to expand its U.S. footprint in Maryland, onshoring parts of its rare-disease portfolio as part of a broader $50 billion pledge. The expansion is...

Ginkgo Bioworks’ Ginkgo Datapoints launched the Virtual Cell Pharmacology Initiative (VCPI), an open-source effort to generate standardized pharmacology data and a reference engineered cell line...

Researchers described a thermally programmed one‑pot CRISPR assay that integrates thermal cycling with CRISPR-based detection to enable rapid, sensitive on-site viral surveillance. The approach,...

France-based Ocean Diagnostics completed a pilot clinical evaluation showing its rapid sepsis identification test matched conventional blood cultures and correlated with mass spectrometry results....

Contineum Therapeutics reported top-line phase II results for PIPE‑307 in relapsing‑remitting multiple sclerosis that failed to meet primary and secondary efficacy endpoints. The M1 receptor...

Scientists unveiled CRISPR PRO‑liveFISH, an improved live‑cell genome imaging method that enhances sensitivity and simplifies targeting of non‑repetitive loci and multi‑locus visualization. The...

Iambic, a San Diego startup, said its physics‑informed algorithms and automated chemistry platforms can deliver small molecules from design to clinic in roughly two years. The company highlighted...

GSK’s Tesaro unit filed suit against AnaptysBio alleging breach of a decade‑old license for the cancer drug Jemperli, while AnaptysBio separately filed a Verified Complaint in Delaware Chancery...

Ginkgo Datapoints launched the Virtual Cell Pharmacology Initiative (VCPI) to generate standardized pharmacology datasets for virtual cell modeling. The program will offer a reference engineered...

France-based Ocean Diagnostics completed a pilot clinical evaluation of its rapid bloodstream infection test in 110 ICU patients at Bordeaux University Hospital and reported 100% concordance with...