Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea

Shots: The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26 Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…

ByDipanshu DixitDecember 12, 2025

EyeYon Medical Receives the US FDA’s IDE Approval to Initiate US Study of EndoArt for Chronic Corneal Edema

Shots: EyeYon Medical secured FDA IDE approval to initiate the first US clinical study of EndoArt, a synthetic endothelial layer and an FDA-designated Breakthrough Device for chronic corneal edema The study will involve 10+ leading US cornea surgeons, evaluating EndoArt as a novel alternative for patients unsuitable for human tissue implantation EndoArt has already seen…

ByPrince GiriDecember 9, 2025

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has accepted sBLA & granted priority review to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy (PDUFA: Dec 5, 2025) sBLA is supported by the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl.…

ByRidhi RastogiAugust 5, 2025

Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea

EyeYon Medical Receives the US FDA’s IDE Approval to Initiate US Study of EndoArt for Chronic Corneal Edema

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

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