Latest Biotech News

GSK said the U.S. FDA has approved zidesamtinib (now marketed as Jideytro) for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer who have received a prior ROS1...

Analysts said Vertex Pharmaceuticals’ plan to acquire Crinetics, with Vertex described as the sole bidder, is likely to reignite investor scrutiny over whether the Boston drugmaker paid too much....

Arrowhead Pharmaceuticals reported positive phase III top-line results for plozasiran (Redemplo) in adults with severe hypertriglyceridemia, setting up a supplemental NDA filing with the FDA...

The U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act (S. 1041), aiming to limit how many patents a biologics sponsor can assert against a biosimilar during the “patent...

NIH launched the Bio Genesis Mission to use AI to accelerate biomedical research, embedded within the broader Genesis Mission initiative created via a White House executive order. The program is...

A UC San Diego-led team reported in Nature Medicine that personalized antisense oligonucleotides (ASOs) reduced seizure frequency in boys with rare SCN2A-related developmental and epileptic...

Freenome closed a SPAC merger with Perceptive Capital Solutions to go public on the Nasdaq under ticker FRNM, raising total gross proceeds of about $310 million. The PIPE includes roughly $240...

Cell-therapy manufacturers are adapting to ambiguous U.S. regulatory guidance on particulates by changing how they demonstrate visible and sub-visible particulate control during manufacturing. A...

The Broad Institute, Boston Children’s Hospital, and the Jackson Laboratory announced the Center for Therapeutic Genetics, a new effort to develop gene therapies for rare diseases and standardize...

10x Genomics said it is on track to stand up a CLIA-certified laboratory at its Pleasanton headquarters campus, with the facility expected to open early next year. The planned lab supports the...

Arrowhead Pharmaceuticals’ plozasiran (Redemplo) delivered “best-case scenario” results in two late-stage trials aimed at expanding use in severe hypertriglyceridemia, the company said...

Agios Pharmaceuticals ended development of its next-generation sickle cell drug tebapivat after Phase 2 results failed to demonstrate a differentiated profile, the company said. Agios’ decision...

Celldex Pharmaceuticals stopped investigating its mast cell-targeting antibody barzolvolimab in prurigo nodularis after a Phase 2 study missed efficacy on all endpoints, the company...

Summit Therapeutics released updated two-year survival data for its Phase 3 HARMONi trial evaluating ivonescimab in non-small cell lung cancer, while the FDA decision clock remains active. The...

Jupiter Neurosciences entered a licensing deal for PharmAla Biotech’s non-racemic MDMA asset ALA-002, granting Jupiter exclusive rights to develop the compound in the U.S. for neuropsychiatric...

Freenome completed its move to public markets through a merger with SPAC Perceptive Capital Solutions, raising gross proceeds of $310 million to accelerate development of its blood-based...

Tempus AI agreed to acquire Personalis in a $1.5 billion deal, adding a molecular residual disease offering built on tumor-informed sequencing to Tempus’ cancer diagnostics portfolio. Tempus said...

Advancell raised an oversubscribed $315 million Series D round to accelerate its global radiopharma strategy, funding late-stage clinical development and expanding isotope supply and manufacturing...

The Broad Institute, Boston Children’s Hospital, and Jackson Laboratory launched a new Center for Therapeutic Genetics aimed at accelerating gene therapy development for rare diseases through...

Cepheid announced an updated third-generation GeneXpert infectious disease PCR platform designed to improve testing speed and multiplex capacity while maintaining compatibility with the existing...