Istituzioni

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

Food and Drug Administration - 12 ore 38 min ago
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation

Food and Drug Administration - Mer, 12/08/2020 - 21:02
FDA has granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Categorie: Istituzioni

FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients

Food and Drug Administration - Mer, 12/08/2020 - 16:33
FDA has issued a final rule to establish compliance requirements for fermented and hydrolyzed foods that bear the gluten-free claim. The rule pertains to foods such as soy sauce, yogurt, sauerkraut, pickles, cheese and green olives.
Categorie: Istituzioni

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

Food and Drug Administration - Mer, 12/08/2020 - 00:11
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

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

Food and Drug Administration - Lun, 10/08/2020 - 22:38
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings

Food and Drug Administration - Sab, 08/08/2020 - 01:06
FDA has approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an IV opioid and for whom alternatives are inadequate.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 7, 2020

Food and Drug Administration - Ven, 07/08/2020 - 22:30
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Food and Drug Administration - Ven, 07/08/2020 - 21:09
FDA approves first liquid biopsy NGS companion diagnostic. This marks the first approval to combine these two technologies — NGS and liquid biopsy — in one diagnostic test in order to guide treatment decisions.
Categorie: Istituzioni

FDA Approves Oral Treatment for Spinal Muscular Atrophy

Food and Drug Administration - Ven, 07/08/2020 - 20:38
The FDA has approved Evrysdi (risdiplam) to treat patients two months and older with spinal muscular atrophy, a rare and often fatal genetic disease affecting muscle strength and movement. This is the second drug and the first oral drug approved to treat this disease.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 6, 2020

Food and Drug Administration - Gio, 06/08/2020 - 23:48
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 5, 2020

Food and Drug Administration - Mer, 05/08/2020 - 23:20
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 4, 2020

Food and Drug Administration - Mer, 05/08/2020 - 00:42
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

La FDA les recomienda a los consumidores que eviten las cebollas rojas de un proveedor en California; la investigación continúa para encontrar la fuente

Food and Drug Administration - Mar, 04/08/2020 - 00:12
La FDA les recomienda a los consumidores que eviten las cebollas rojas de un proveedor en California; la investigación continúa para encontrar la fuente.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 3, 2020

Food and Drug Administration - Lun, 03/08/2020 - 23:02
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease

Food and Drug Administration - Sab, 01/08/2020 - 02:54
The FDA has approved a new indication for drug to treat seizures associated with tuberous sclerosis complex.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Food and Drug Administration - Sab, 01/08/2020 - 01:16
Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 31, 2020

Food and Drug Administration - Ven, 31/07/2020 - 22:56
FDA's actions on July 31, 2020 in its ongoing response to the COVID-19 pandemic.
Categorie: Istituzioni

FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging

Food and Drug Administration - Ven, 31/07/2020 - 16:28
The FDA is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the U.S.
Categorie: Istituzioni

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

Food and Drug Administration - Gio, 30/07/2020 - 23:33
FDA's actions on July 30, 2020in the ongoing response to the COVID-19 pandemic
Categorie: Istituzioni

FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

Food and Drug Administration - Gio, 30/07/2020 - 21:25
The FDA announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, such as the water used in farm irrigation systems.
Categorie: Istituzioni