The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...

The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...

In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO ...

Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant ...

In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer ...

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application ...

Participants in trials of BrainStorm Cell Therapeutics' NurOwn filed a Citizens’ Petition with the FDA earlier this month ...

Seven biotech unicorns are advancing AI-powered drug discovery and development—but must contend with a difficult investing ...

Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical ...

Some of the most high-profile acquisitions in recent years have involved women-fronted biotechs. BioSpace reviews five of the ...

FDA reviewers flag "discordant results" in a briefing document published ahead of Friday's advisory committee meeting for the ...