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

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

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

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

Phase 2 filing on track for Q1 2025 "The acceptance of our third U.S. IND is an important milestone for Aligos,” said ...

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 ...

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 ...

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.

NanoViricides, Inc. (NYSE Amer.: NNVC ) (the “Company”), a clinical stage global leader in broad-spectrum antiviral ...

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