Latest Biotech News

Samsung Biologics announced an all-cash tender offer to acquire peptide CDMO PolyPeptide Group AG for about CHF 1.46 billion (roughly $1.8 billion), positioning the South Korean contract...

GSK secured U.S. FDA approval for zidesamtinib (branded Jideytro) in ROS1-positive non-small-cell lung cancer, delivering an unusually fast regulatory win for the company just after its $10.6...

The FDA approved Nuvalent’s lung cancer medicine on Wednesday—about two months earlier than projected—highlighting early execution from GSK’s newly completed $10.6 billion Nuvalent acquisition....

Arrowhead Pharmaceuticals reported positive top-line results from two late-stage phase III trials of plozasiran (Redemplo) in severe hypertriglyceridemia, with data described as a “best-case...

Arrowhead’s plozasiran results in severe hypertriglyceridemia also position the gene-silencing therapy closer to direct competition with Ionis Pharmaceuticals’ RNA-targeted option for the same...

Celldex Therapeutics moved to discontinue its mast cell-targeting monoclonal antibody barzolvolimab in prurigo nodularis after a phase II study missed its primary and key secondary endpoints. The...

The FDA launched its PreCheck Pilot Program to strengthen domestic pharmaceutical manufacturing capacity by moving regulator engagement earlier into facility design and construction. Under the...

The U.S. Senate unanimously approved the Affordable Prescriptions for Patients Act (S. 1041), a bill intended to reduce patent thickets that can delay biosimilar entry. The measure limits the...

Assured Health raised $19 million to expand agentic AI tools for verifying provider credentials and accelerating insurance enrollment for health systems and group practices. The company says the...

NIH announced the Bio Genesis Mission to accelerate biomedical research using artificial intelligence, nested within the broader Genesis Mission launched via an executive order. The initiative is...

GSK scored an early FDA win for zidesamtinib, now branded Jideytro, following its $10.6 billion acquisition of Nuvalent. The U.S. approval covers adults with locally advanced or metastatic...

Arrowhead Pharmaceuticals reported positive late-stage results for plozasiran (Redemplo) in severe hypertriglyceridemia, aiming to expand beyond its rare-disease label. In two phase III trials,...

The U.S. Senate advanced a bill aimed at limiting biologics patent thickets and narrowing how many patents sponsors can assert against biosimilars under the Biologics Price Competition and...

Celldex ended development in prurigo nodularis after its KIT inhibitor barzolvolimab missed efficacy measures in a phase II study, according to a company update. The decision follows investor...

A UC San Diego-led team reported in Nature Medicine that personalized antisense oligonucleotides reduced seizure burden in two children with SCN2A-related developmental and epileptic...

Advancell secured an oversubscribed $315 million Series D to accelerate its push toward an integrated global radiopharma platform. The funding is intended to support late-stage clinical...

Cepheid announced a third-generation GeneXpert infectious disease system update aimed at faster turnaround and higher multiplex capacity while maintaining compatibility with existing assay menus....

The FDA launched its PreCheck Pilot program to strengthen domestic pharmaceutical manufacturing by providing earlier facility-focused feedback to selected companies before applications are filed....

The NIH announced Bio Genesis Mission, an initiative to leverage artificial intelligence to accelerate biomedical research under the broader Genesis Mission framework. The White House said more...

Triplebar Bio, with support from the National Science Foundation and BioMADE, is developing an AI-informed cell engineering model designed specifically for biomanufacturing environments. The...