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 ...

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 ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...

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

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 ...

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 ...

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

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

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

After two previous failed attempts with the FDA, AbbVie now has one more offering in its lineup — a critical step as it ...