Lea Eslava-Kim, PharmD

A post-exposure treatment for rabies successfully met its primary endpoint of non-inferiority when measured against an IgG reference product.

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for Vaxchora (PaxVax), a single-dose oral cholera vaccine.

Astellas announced that topline data from the a phase 3 trial, SECURE, which evaluated Cresemba (isavuconazonium sulfate) in adult patients with invasive aspergillosis.

The FDA has granted Breakthrough Therapy designation to RBX2660, a Microbiota Restoration Therapy (MRT), for the treatment of recurrent Clostridium difficile infection (CDI).

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1129 (Viamet) for the treatment of cryptococcal meningitis.

Gilead Sciences announced topline results from four Phase 3 clinical studies evaluating the once-daily, fixed-dose combination of sofosbuvir (SOF) with velpatasvir (VEL) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.

Allergan announced positive topline results from two pivotal phase 3 studies for ceftazidime-avibactam (Avycaz) as a treatment for adult hospitalized patients with complicated urinary tract infections.

Gilead announced that phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infection met its primary objective.

Pfizer announced positive topline results for Trumenba (meningococcal group B vaccine) in two phase-3 trials.

The FDA has accepted the new drug application for grazoprevir/elbasvir (Merck) for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4, or 6.