FDA Approves Diagnostic Test for Lupus and ANCA-Associated Vasculitis
The U.S. Food and Drug Administration has approved new automated diagnostic tests for lupus and ANCA-associated vasculitis.
Rituxan Approved to Treat Severe Pemphigus Vulgaris
The U.S. Food and Drug Administration has approved Genentech’s Rituxan (rituximab) to treat moderate-tosevere phemphigus vulgaris.
FDA Approves Fast-Acting, Single-Dose Flu Medication
The U.S. Food and Drug Administration (FDA) has approved a new, single-dose medication to treat people 12 years and older who have had the flu for no more than 48 hours.
First EpiPen Generics Get FDA Approval
FDA has approved the first generic versions of Mylan’s EpiPen and EpiPen Jr.
FDA Approves HPV Vaccine for 27- to 45-Year-Old Men and Women
Merck’s Gardasil 9 human papillomavirus (HPV) vaccine has been approved by the U.S. Food and Drug Administration (FDA) for an expanded indication for men and women between the ages of 27 years and 45 years.
CDC OKs FluMist for 2018-19 Influenza Season
The Centers for Disease Control and Prevention’s advisory committee has voted 12-2 to recommend FluMist, the nasal spray version of the influenza vaccine, be used during the 2018-19 influenza (flu) season.
FDA Chooses Influenza Vaccine Strains for the 2018-19 Season
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee chose the Northern Hemisphere’s 2018-19 influenza (flu) vaccine strains based on the World Health Organization’s recommendations.
FDA Approves First Treatment for High-Risk Prostate Cancer
The U.S. Food and Drug Administration has approved Erleada (apalutamide) to treat men with prostate cancer that has not yet spread but has a quickly rising PSA level while on treatment with hormone therapy, which causes concern for cancer growth and spread.
Zika Virus Blood Screening Guidelines Revised by FDA
The Food and Drug Administration has revised its recommendations for testing blood donations for the Zika virus.
VONVENDI Approved to Treat Von Willebrand Disease
The U.S. Food and Drug Administration has approved Shire’s VONVENDI, a recombinant von Willebrand factor treatment for perioperative management of bleeding in adults 18 years and older with von Willebrand disease.
