FDA Approvals Calendar
Found 25 Results
The treatment of smallpox disease caused by variola virus in adults and pediatric patients
May 22, 2018 12:00AM - May 22, 2018 12:00AM
Committee: Antimicrobial Drugs,
Indication: The treatment of smallpox disease caused by variola virus in adults and pediatric patients
Drug/Device: tecovirimat (generic and commercial)
Sponsor: SIGA Technologies, Inc.
The treatment of complicated urinary tract infections and blood stream infections in adults.
May 22, 2018 12:00AM - May 22, 2018 12:00AM
Committee: Antimicrobial Drugs,
Indication: The treatment of smallpox disease caused by variola virus in adults and pediatric patients
Drug/Device: tecovirimat (generic and commercial)
Sponsor: SIGA Technologies, Inc.
As an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.
May 10, 2018 12:00AM - May 10, 2018 12:00AM
Committee: Endocrinologic and Metabolic Drugs Advisory Committee
Indication: As an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.
Drug/Device: volanesoren solution for subcutaneous injection
Sponsor: Akcea Therapeutics, Inc.