Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 18, 2020

Food and Drug Administration - Gi, 18/06/2020 - 23:17
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

Food and Drug Administration - Gi, 18/06/2020 - 19:20
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.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

Food and Drug Administration - Gi, 18/06/2020 - 16:42
FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020

Food and Drug Administration - Me, 17/06/2020 - 22:41
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk

Food and Drug Administration - Me, 17/06/2020 - 21:54
The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 16, 2020

Food and Drug Administration - Me, 17/06/2020 - 03:12
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling

Food and Drug Administration - Me, 17/06/2020 - 02:29
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.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test

Food and Drug Administration - Me, 17/06/2020 - 01:56
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.
Categorie: Istituzioni

FDA Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease

Food and Drug Administration - Ma, 16/06/2020 - 21:51
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.
Categorie: Istituzioni

FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic

Food and Drug Administration - Ma, 16/06/2020 - 17:24
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.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 15, 2020

Food and Drug Administration - Ma, 16/06/2020 - 02:02
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use

Food and Drug Administration - Lu, 15/06/2020 - 22:08
FDA is warning about a potential drug interaction with remdesivir, which received emergency use authorization to treat hospitalized COVID-19 patients with severe disease.
Categorie: Istituzioni

FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

Food and Drug Administration - Lu, 15/06/2020 - 20:51
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
Categorie: Istituzioni

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

Food and Drug Administration - Lu, 15/06/2020 - 18:30
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 12, 2020

Food and Drug Administration - Ve, 12/06/2020 - 23:58
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves Drug to Treat Infants and Children with HIV

Food and Drug Administration - Ve, 12/06/2020 - 20:03
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.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 11, 2020

Food and Drug Administration - Gi, 11/06/2020 - 23:27
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

Food and Drug Administration - Gi, 11/06/2020 - 22:34
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.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 10, 2020

Food and Drug Administration - Me, 10/06/2020 - 23:49
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

Food and Drug Administration - Me, 10/06/2020 - 18:51
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
Categorie: Istituzioni
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