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Vyleesi (bremelanotide) has been approved to treat acquired

Vyleesi Approved for Hypoactive Sexual Desire Disorder in Women

FDA approved Vyleesi for premenopausal women; drug administered by subcutaneous injection
The indication for a cystic fibrosis treatment

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
Victoza (liraglutide) injection is now approved to treat type 2 diabetes in children 10 years and older

FDA Approves Victoza Injection for Children 10 Years and Older

~64 percent of children treated with Victoza achieved HbA1c levels less than 7 percent
The IB-Stim has received marketing approval from the U.S. Food and Drug Administration as the first medical device used to help alleviate functional abdominal pain in 11- to 18-year-old patients with irritable bowel syndrome

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
Polivy (polatuzumab vedotin-piiq)

Chemoimmunotherapy Regimen Approved to Treat DLBCL

Polivy approved in combination with bendamustine, rituximab for diffuse large B-cell lymphoma
The U.S. Food and Drug Administration granted Emgality (galcanezumab-gnlm) solution the first approval for treating episodic cluster headache

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 (ceftolozane and tazobactam) has been approved for a new indication to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients aged 18 years and older

Zerbaxa Approved for Hospital-Acquired Bacterial Pneumonia

Drug previously approved for treatment of complicated intra-abdominal infections, UTIs
The U.S. Food and Drug Administration took a good look at the safety and effectiveness of cannabidiol products on Friday

FDA Takes Hard Look at CBD

CBD products have swamped the market due to change in federal law, not because of new medical evidence
A public meeting on cannabidiol (CBD) products will be held Friday by the U.S. Food and Drug Administration

FDA to Hold First Public Meeting on CBD

Scheduled speakers will include doctors, consumers, and cannabis industry members
Piqray (alpelisib) tablets were approved for the treatment of hormone receptor-positive

First PI3K Inhibitor Approved for Metastatic, Advanced Breast Cancer

Piqray approved for HR-positive, HER2-negative, PIK3CA-mutated, metastatic or advanced breast cancer