The high-profile obesity drug developer priced the biotech sector’s biggest offering since 2022 and will use the proceeds to ...

If confirmed by the Senate, Schwartz could finally fill a void for an agency that’s cycled through multiple leaders over the last year.

The Swiss drugmaker, which owns rights to the Duchenne gene therapy outside the U.S., hopes the trial will yield additional ...

The findings, which come amid FDA scrutiny of Foundayo’s safety, will enable Lilly to seek a new clearance in diabetes.

The agency’s decision to hold an advisory committee meeting on the topic comes after HHS Secretary Robert F. Kennedy Jr. told ...

The request, which is part of a just-released approval letter for Foundayo, comes amid an intensifying marketing battle ...

Replimune is laying off 63 staffers days after the second FDA rejection of its melanoma drug. Elsewhere, Revolution raised $2 billion and a regulatory filing revealed details on negotiations between ...

The combined company will trade on the Nasdaq under the ticker OBX. It has also secured commitments for a private placement ...

The therapy, which works similarly to Takeda’s blockbuster Entyvio, showed remission rates that suggest a “best-in-class” ...

Novo intends to “fully integrate” AI capabilities across its operations. Elsewhere, Regeneron made its first foray into ...

The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity ...

The estimated 6,000 women a day who reach menopause experience it differently. Some have debilitating, vasomotor symptoms ...