The clearance, issued 54 days after an approval submission, gives Novo another chance to claw back market share from Eli Lilly.

Retatrutide, a possible advance on GLP-1 drugs like Zepbound, significantly cut blood sugar and body weight in the study, a sign it might be similarly impactful against obesity.

While sales of Talzenna, which Pfizer acquired in a $14 billion deal, have been “negligible” so far, the new results should ...

The planned Shanghai facility extends a yearslong push into the field and will support CAR-T therapies AstraZeneca is making for autoimmune disease and cancer.

As part of a larger review, analyst Leonid Timashev identified 13 companies that could see deal interest as well as more than half a dozen poised to be potential buyers.

Backed by more than a dozen investors, the biotech startup will use the funding to further a Phase 1 trial of its lead program CBX-250.

The clearance is the first for an oral peptide that blocks IL-23, the target of popular medicines like Skyrizi and Tremfya. J ...

Aspen Neuroscience presented positive Phase 1/2 data for its stem cell-derived therapy. Elsewhere, Aldeyra lost over half its market value following a rejection from the FDA.

Biotechnology startup Ventus Therapeutics is licensing its lead research program, a drug candidate for inflammatory disorders, to Novo Nordisk in exchange for $70 million. The experimental drug, ...

The funding, which ranks as one of the largest of its kind for a China-based drug startup, will support a portfolio of ...

The company now expects a longer path to approval than anticipated, leading it to deprioritize a therapy billed as a threat to Pfizer’s fast-selling bladder cancer drug.

The ruling, related to a lawsuit from several major medical organizations, stated that HHS ignored established protocols in altering the childhood immunization schedule and overhauling a key CDC panel ...