FDA Approvals Calendar
Found 25 Results
Oncologic Committee Votes Against Quizartinib
May 14, 2019 12:00AM - May 14, 2019 12:00AM
Committee: Oncologic Drugs Advisory Committee
Indications: the treatment of adults with relapsed or refractory acute myeloid leukemia which is FLT3-ITD positive, as detected by an FDA-approved test
Drug/Device: Drug - ...
Pexidartinib Gets Receives Support to Treat Giant Cell Tumors
May 14, 2019 12:00AM - May 14, 2019 12:00AM
Committee: Oncologic Drugs Advisory Committee
Indications: the treatment of adult patients with symptomatic tenosynovial giant cell tumor also referred to as giant cell tumor of the tendon sheath or pigmented ...
Dry Powder Mannitol Passes FDA Committee
May 8, 2019 12:00AM - May 8, 2019 12:00AM
Committee: Pulmonary-Allergy Drugs Advisory Committee (PADAC)
Indications: Dry Powder Mannitol (DPM) in management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction ...