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

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

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 ...

Amneal Pharmaceuticals (AMRX) announced it has received FDA approval of its New Drug Application for Pyridostigmine Bromide ...

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

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

The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...

Lo, PhD, has been appointed the new Editor-in-Chief of the journal ASSAY and Drug Development Technologies. Dr. Lo is ...

After two previous failed attempts with the FDA, AbbVie now has one more offering in its lineup — a critical step as it ...