The coming flu season is the clearest indication yet that biopharma’s long-standing assumptions about predictability, ...

New interim data from a Phase III trial puts the company on track to file for FDA approval next year in an indication that ...

Lynkuet is the first FDA-approved therapy that blocks both the neurokinin 1 and neurokinin 3 receptors to treat hot flashes.

Editor’s Note: This deep dive was originally published Sept. 24, 2025, as a special edition of Biopharm Executive. Subscribe ...

Intellia earlier this year reported a similar grade 4 liver enzyme elevation associated with the gene therapy nexiguran ...

The takeover of its competitor, announced Sunday, could also bring some attention to Dyne Therapeutics, which has a similar ...

Executives from Eli Lilly, Merck and other companies foresee the FDA's new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate ...

Pivotal results from uniQure’s gene therapy for Huntington’s disease have brought new light to patients who have known only ...

The BioSpace 40 Under 40 winner opens up about his very personal career transformation from wealth management to biotech—and ...

Last month, “historic positive results” from uniQure’s gene therapy snapped the Huntington’s community out of years of failure. As the biotech prepares to submit for FDA approval, BioSpace looks at ...

The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved ...

The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in ...