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 ...

Valuation wise, Paradigm Biopharmaceuticals (ASX:PAR) is what Winston Churchill referred to as a riddle wrapped in a mystery ...

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

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

CAM2029 is a novel depot formulation of octreotide, a somatostatin analogue, administered subcutaneously once monthly.

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 ...

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.

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 ...

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