FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA

Organization: FDA
Category: Governmental Organizations
URL: https://www.fda.gov/

FDA approves Epidiolex ( cannabidiol )

June 25, 2018, The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

FDA approves Moxidectin

On June 13, the FDA approved moxidectin for the treatment of onchocerciasis (river blindness) in patients 12 years of age and older by oral administration of 8 mg per day (4 tablets of 2 mg tablets).

Onchocerciasis is the second leading cause of blindness in the world following trachoma, mossy dermatitis, subcutaneous nodules and visual impairment caused by parasitic nematodes parasitic on human skin, subcutaneous tissue and eyes. A parasitic disease characterized by river blindness or filariasis.

FDA approves Olumiant ( baricitinib )

Rheumatoid arthritis is a chronic, prone to progressive arthritis that is very painful. Currently, TNF inhibitors are a common rheumatoid arthritis therapy, but about two-thirds of patients are unable to get clinical remission from the first treatment. And over time, a large number of patients are unable to maintain the efficacy of the drug. Therefore, these patients urgently need an innovative drug to alleviate the disease.

FDA approves Palynziq ( pegvaliase-pqpz )

May 24, 2018, The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Palynziq is a novel enzyme therapy for adult PKU patients who have uncontrolled blood Phe concentrations on current treatment.

FDA approves Aimovig ( erenumab-aooe )

May 17, 2018, The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

FDA approves Lucemyra ( lofexidine hydrochloride )

May 16, 2018, The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

FDA approves Akynzeo (fosnetupitant, palonosetron)

Akynzeo is a compound intravenous injection of the 5-HT3 receptor antagonist palonosetron and the NK-1 receptor antagonist fosnetupitant to prevent nausea and vomiting in chemotherapy patients with cancer.
Palonosetron was approved in 2008 for the prevention of nausea and vomiting in the acute phase (within 24 hours) after the start of cancer chemotherapy. Fosnetupitant is a new drug used to prevent nausea and vomiting in the acute and delayed phases (25 hours to 120 hours after chemotherapy) after cancer chemotherapy begins.

FDA approves Crysvita (burosumab-twza)

April 17, 2018, The U.S. Food and Drug Administration today approved Crysvita (burosumab-twza), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.