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 ...
The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic ...
LNZ100 is a single-use, once-daily eye drop containing aceclidine, a small molecule acetylcholine receptor agonist that causes miosis.
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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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 ...
A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of ...
Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.
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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 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 ...
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Avadel wins FDA approval for narcolepsy drug Lumryz in childrenThe 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 ...
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