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

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.

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 ...

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

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

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

In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...

PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved "The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN ...

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 ...

Bayer notches up pressure on rival Astellas’ Veozah with an EU marketing authorisation application for its hot flash relief ...