ADRX-0405 is a novel antibody-drug conjugate targeting STEAP1, and a phase 1a/b study will investigate the agent for the ...

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

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 approval for an experimental medication for the neurological condition.

Curanex Pharmaceuticals (CURX) has filed for a proposed $10M initial public offering. According to an SEC filing, Curanex is ...

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

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

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

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 ...

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 ...