Istituzioni

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

Coronavirus (COVID-19) Update

Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to discuss the first request for emergency use authorization for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.

FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.

Coronavirus (COVID-19) Update

Today, the FDA authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).

Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update

The FDA has approved the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17, 2020 to discuss Moderna’s emergency use authorization request for a COVID-19 vaccine.

The FDA issued guidance on the use of dry heat for bioburden reduction to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply during the COVID-19 public health emergency.

Coronavirus (COVID-19) Update

Today, the FDA approved the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder which causes recurrent kidney stones and loss of kidney function.

Coronavirus (COVID-19) Update, November 23, 2020

Today, the FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu.

Today, the FDA issued an emergency use authorization for two monoclonal antibodies to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19.

Coronavirus (COVID-19) Update

Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford Progeria Syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older.

FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10, 2020 to discuss Pfizer and BioNTech’s emergency use authorization request for a COVID-19 vaccine.