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Coronavirus (COVID-19) Update: Daily Roundup

The FDA has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones.

FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

Coronavirus (COVID-19) Update: Daily Roundup

The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.

Coronavirus (COVID-19) Update: Daily Roundup

Today, the FDA posted template updates on the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.

Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.

FDA approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

The FDA has issued warning letters to four companies for selling unapproved injectable homeopathic drugs that pose significant risks to patient health and violate federal law.

Coronavirus (COVID-19) Update: Daily Roundup

FDA is warning about a potential drug interaction with remdesivir, which received emergency use authorization to treat hospitalized COVID-19 patients with severe disease.

FDA permits marketing of the first game-based digital therapeutic device to improve attention function in children with ADHD. The game-based device, EndeavorRx, is for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Coronavirus (COVID-19) Update: Daily Roundup

FDA approves Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.

Coronavirus (COVID-19) Update: Daily Roundup

FDA approved Uplizna for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are positive for antibody called AQP4. NMOSD is a rare autoimmune disease that attacks the optic nerves and spinal cord. Uplizna is the second approved treatment for the disorder.

Coronavirus (COVID-19) Update: Daily Roundup

FDA authorizes the Illumina COVIDSeq Test - returns diagnostic results about a patient’s SARS-CoV-2 infection status and generates information about potential virus mutations