The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...
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Avadel Obtains FDA Nod for Label Expansion of Narcolepsy Drug LumryzAvadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...
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Intercept’s liver disease drug Ocaliva faces FDA approval delayAn FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
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 ...
A slate of popular policies commonly bandied about to help reduce drug costs would each cut average prices by only a handful of percentage points, according to a recent Congressional Budget Office ...
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 ...
KT-621 has demonstrated dupilumab-like activity and was well tolerated ina wide variety of preclinical models of TH2 diseasesKT-621 is expected ...
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...
After two previous failed attempts with the FDA, AbbVie now has one more offering in its lineup — a critical step as it ...
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