The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic ...

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

LNZ100 is a single-use, once-daily eye drop containing aceclidine, a small molecule acetylcholine receptor agonist that causes miosis.

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 ...

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 ...

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

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

In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist ...

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

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

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

The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...