Drug Approval | April 15, 2023
NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate
Study efficacy measures will include the expression of dystrophin protein and motor function.
Study efficacy measures will include the expression of dystrophin protein and motor function.
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States
Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms
Acetazolamide is used to treat glaucoma
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
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