One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial. More than ...

Makary’s exit ends a turbulent run marred by leadership upheaval, mass layoffs, political pressure and public spats with ...

A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.

Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted ...

The wide-ranging pact involves as many as 13 drugs and marks the latest example of the growing relationship between Chinese ...

Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly ...

Journavx revived an area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?

The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.

A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way ...

Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA ...

Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.

AbbVie will pay $200 million to acquire privately held Nimble Therapeutics and its pipeline of oral peptide drugs for immune diseases like psoriasis and inflammatory bowel disease, the pharmaceutical ...