A patient has died while taking a closely watched gene therapy for muscular dystrophy. Sarepta Therapeutics announced the ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...

On Monday, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Monogram Technologies Inc.’s (NASDAQ:MGRM ...

The FDA first approved eculizumab for use in adult patients with generalized myasthenia gravis in 2017, before expanding the ...

Monogram received FDA 510(k) clearance for its robotic-assisted total knee arthroplasty system, Monogram mBôs TKA. The company plans initial placements with key surgeons and aims to expand its ...

Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, ...

Rogaine was approved by the Food and Drug Administration in 1988, the first drug to win the agency’s endorsement for male ...

ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to ...

Striate+ was the first product approved for dental GBR applications ... The company recently noted that it remains on track to gain US FDA 510(k) regulatory clearance to commercially distribute ...

Monogram Technologies secured 510(k) clearance for its robotic knee replacement system, while Vicarious Surgical blamed ...