LENZ Therapeutics said the submission for the treatment of presbyopia is supported by the positive data results from a Phase 3 study. Aceclidine is a new chemical entity in the U.S. and isn't approved ...

An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...

New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...

Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.

The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...

In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...

The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...

The NDA submission for the treatment of presbyopia is supported by the positive data results from the pivotal Phase 3 CLARITY study. Aceclidine is a new chemical entity in the United States and is not ...

A slate of popular policies commonly bandied about to help reduce drug costs would each cut average prices by only a handful of percentage points, according to a recent Congressional Budget Office ...

Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. But with ...

AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...

Diet and diabetes drugs like Ozempic and Mounjaro could also help people struggling with alcohol and opioid abuse, according ...