New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...
Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.
The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
LNZ100 is a single-use, once-daily eye drop containing aceclidine, a small molecule acetylcholine receptor agonist that causes miosis.
Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...
In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...
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 ...
Diet and diabetes drugs like Ozempic and Mounjaro could also help people struggling with alcohol and opioid abuse, according ...
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...