Istituzioni

Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test

Food and Drug Administration - Lu, 06/07/2020 - 19:29
FDA issued an EUA for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Food and Drug Administration - Ve, 03/07/2020 - 01:13
The FDA has issued an EUA for another combination diagnostic that can test for flu and COVID-19 to prepare for this upcoming flu season.
Categorie: Istituzioni

FDA Approves New HIV Treatment for Patients With Limited Treatment Options

Food and Drug Administration - Gi, 02/07/2020 - 22:40
FDA approved Rukobia (fostemsavir), a new antiretroviral medication for adult patients with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 2, 2020

Food and Drug Administration - Gi, 02/07/2020 - 22:26
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

Food and Drug Administration - Gi, 02/07/2020 - 20:28
FDA is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol that is dangerous and not an acceptable active ingredient for hand sanitizer products.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020

Food and Drug Administration - Gi, 02/07/2020 - 00:17
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020

Food and Drug Administration - Ma, 30/06/2020 - 22:35
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

Food and Drug Administration - Ma, 30/06/2020 - 17:11
The FDA is taking important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 29, 2020

Food and Drug Administration - Lu, 29/06/2020 - 23:55
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

Food and Drug Administration - Lu, 29/06/2020 - 21:38
FDA approves Keytruda for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Categorie: Istituzioni

FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

Food and Drug Administration - Lu, 29/06/2020 - 17:55
FDA approves Phesgo to treat adult patients with HER2-positive breast cancer. Phesgo can be administered at home by a health care professional once chemotherapy is finished.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 26, 2020

Food and Drug Administration - Ve, 26/06/2020 - 22:29
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves New Therapy for Dravet Syndrome

Food and Drug Administration - Ve, 26/06/2020 - 02:16
FDA approves Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 25, 2020

Food and Drug Administration - Gi, 25/06/2020 - 22:39
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 24, 2020

Food and Drug Administration - Gi, 25/06/2020 - 00:09
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19

Food and Drug Administration - Me, 24/06/2020 - 21:58
U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 23, 2020

Food and Drug Administration - Ma, 23/06/2020 - 22:45
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials

Food and Drug Administration - Ma, 23/06/2020 - 21:29
FDA launches Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup June 22, 2020

Food and Drug Administration - Lu, 22/06/2020 - 23:06
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

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

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