Tag: Food & Drug Administration
Vyleesi Approved for Hypoactive Sexual Desire Disorder in Women
FDA approved Vyleesi for premenopausal women; drug administered by subcutaneous injection
FDA Expands Cystic Fibrosis Treatment Approval to Children Ages 6 to 12
Symdeko previously approved for patients ≥12 years with cystic fibrosis and certain genetic mutations
FDA Approves Victoza Injection for Children 10 Years and Older
~64 percent of children treated with Victoza achieved HbA1c levels less than 7 percent
Marketing OK’d for Device to Help Reduce IBS Symptoms in Adolescents
IB-Stim helps to reduce abdominal pain in 11- to 18-year-olds with irritable bowel syndrome
Chemoimmunotherapy Regimen Approved to Treat DLBCL
Polivy approved in combination with bendamustine, rituximab for diffuse large B-cell lymphoma
Emgality Receives First FDA Approval for Treating Cluster Headache
Patients treated with Emgality had 8.7 fewer cluster headache attacks at 3.0 weeks versus 5.2 with placebo
Zerbaxa Approved for Hospital-Acquired Bacterial Pneumonia
Drug previously approved for treatment of complicated intra-abdominal infections, UTIs
FDA Takes Hard Look at CBD
CBD products have swamped the market due to change in federal law, not because of new medical evidence
FDA to Hold First Public Meeting on CBD
Scheduled speakers will include doctors, consumers, and cannabis industry members
First PI3K Inhibitor Approved for Metastatic, Advanced Breast Cancer
Piqray approved for HR-positive, HER2-negative, PIK3CA-mutated, metastatic or advanced breast cancer
