Coronavirus (COVID-19) Update: Daily Roundup

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.

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.

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

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.

Coronavirus (COVID-19) Update: Daily Roundup

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.

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.

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

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

Coronavirus (COVID-19) Update: Daily Roundup

The FDA has approved a new indication for drug to treat seizures associated with tuberous sclerosis complex.

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

FDA's actions on July 31, 2020 in its ongoing response to the COVID-19 pandemic.

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.

FDA's actions on July 30, 2020in the ongoing response to the COVID-19 pandemic

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.