Istituzioni
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Categorie: Istituzioni
Coronavirus (COVID-19) Update: December 10, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System
FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: December 8, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples
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).
Categorie: Istituzioni
Coronavirus (COVID-19) Update: December 4, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
Coronavirus (COVID-19) Update: December 3, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
Coronavirus (COVID-19) Update: December 1, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: November 24, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
FDA Approves First Drug to Treat Rare Metabolic Disorder
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: November 23, 2020
Coronavirus (COVID-19) Update, November 23, 2020
Categorie: Istituzioni
FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: November 20, 2020
Coronavirus (COVID-19) Update
Categorie: Istituzioni
FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
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.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
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.
Categorie: Istituzioni
