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 ...
The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
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 ...
New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...
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.
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. But with ...
In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specia ...
KT-621 has demonstrated dupilumab-like activity and was well tolerated ina wide variety of preclinical models of TH2 diseasesKT-621 is expected ...