Rezafungin Gets Priority Review for Candidemia, Invasive Candidiasis
The NDA is supported by data from a phase 3 study, which compared rezafungin to caspofungin in adults diagnosed with candidemia and/or invasive candidiasis.
Fungal Infections
Vivjoa Now Available for Recurrent Vulvovaginal Candidiasis
Vivjoa is a novel oral inhibitor of fungal CYP51.
Vivjoa Approved for Recurrent Vulvovaginal Candidiasis
The approval was based on data from three phase 3 trials, which included female patients aged 12 years and older with at least 3 episodes of acute VVC in the past 12 months.
Study Shows Ibrexafungerp Prevents Recurrent Vulvovaginal Candidiasis
The phase 3 CANDLE study compared the efficacy and safety of ibrexafungerp to placebo in 260 female patients 12 years of age and older with rVVC.
Rezafungin Promising as First-Line Tx for Candidemia, Invasive Candidiasis
The pivotal phase 3 ReSTORE study included 187 adults diagnosed with candidemia and/or invasive candidiasis.
Lotrimin, Tinactin Spray Products Recalled Due to Presence of Benzene
Lotrimin and Tinactin spray products are over the counter topical antifungals.
Treatment for Pneumocystis Pneumonia Recalled Due to Temperature Control Issue
The recall was initiated because the product had prolonged exposure to extremely cold weather during shipment.
Oteseconazole Gets Priority Review for Recurrent Vulvovaginal Candidiasis
The NDA submission is supported by data from three phase 3 trials, which included 2 global studies and one US-focused study.
‘Superbug’ Fungus Spreads Among Vulnerable in 2 US Cities
There were 101 Candida auris cases at a nursing home and 22 cases at hospitals from January to April
