Approval Recommended for Zinplava to Prevent Recurrence of C. Diff

The U.S. Food and Drug Administration approved bezlotoxumab (Zinplava, Merck) to prevent the recurrence of Clostridium difficile (C. diff) infection (CDI) in patients aged 18years and older.
FDA Approves Sandoz’s Erelzi as Biosimilar to Amgen’s Enbrel

The U.S. Food and Drug Administration has approved Erelzi (etanercept-szzs), the first biosimilar etanercept, for all indications included in the reference product’s label.
HHS Awards Millions to Improve Healthcare

The Department of Health and Human Services awarded nearly $156 million in funding to support 420 health centers in 47 states, the District of Columbia and Puerto Rico to increase access to integrated oral healthcare services and to improve oral health outcomes for Health Center Program patients.
FDA Approves Amgen’s Amjevita as a Biosimilar to Humira

The U.S. Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of several autoimmune conditions.
FDA Approves Vemlidy to Treat Chronic Hepatitis B Virus Infection

The U.S. Food and Drug Administration has approved Gilead Sciences’ Vemlidy (tenofovir alafenamide,TAF) 25 mg once-daily treatment for adults with chronic hepatitis B virus(HBV) infection with compensated liver disease.
Vaccine for Lung Cancer Approved for Clinical Trial

A lung cancer vaccine developed in Cuba has been approved by the U.S. Food and Drug Administration for a clinical trial at Roswell Park Cancer Institute in Buffalo, N.Y.
IDELVION Prevents Bleeds and Reduces Drug Consumption in Hemophilia B Patients

Results from the Phase III PROLONG9FP ongoing extension clinical development program evaluating the long-term efficacy and safety of IDELVION (coagulation factor IX [recombinant], albumin fusion protein) showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption.
Dusquetide Granted Orphan Drug Status to Treat Life-Threatening Immune Disorder

The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
FDA Approves Cabometyx for Advanced Renal Cell Carcinoma

The U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
GSK’s Shingles Vaccine Effective in Adults 70-Plus Years Old

A randomized Phase III study (ZOE-70) of GlaxoSmithKline’s investigational shingles vaccine, Shingrix, showed 90 percent efficacy in adults aged 70 years and older that is maintained for at least four years.