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

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

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 ...

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 ...

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

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

Novartis has lost a bid to keep a generic version of its top-selling heart failure drug Entresto off the U.S. market by ...

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

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

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

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

Innovative application of an existing drug offers promising alternative treatment to traditional chemotherapy for patients with appendix cancer.