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

Evaxion Licenses EVX-B3 Vaccine Candidate to Merck

Shots: Evaxion has granted Merck the rights to EVX-B3, a preclinical vaccine candidate under their Sep 2024 option & license agreement As per the deal, Merck will assume full responsibility & costs of further development of EVX-B3 in exchange for $7.5M upfront & ~$592M in development, regulatory & sales milestones, with net sales-based royalties EVX-B3…

ByRidhi RastogiSeptember 26, 2025

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…

ByRidhi RastogiMarch 31, 2025

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

Evaxion Licenses EVX-B3 Vaccine Candidate to Merck

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

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