Istituzioni

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

Food and Drug Administration - Ve, 11/12/2020 - 12:53
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 10, 2020

Food and Drug Administration - Gi, 10/12/2020 - 23:50
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

Food and Drug Administration - Gi, 10/12/2020 - 15:21
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

Food and Drug Administration - Me, 09/12/2020 - 23:53
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

Food and Drug Administration - Me, 09/12/2020 - 00:20
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

Food and Drug Administration - Sa, 05/12/2020 - 02:05
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

Food and Drug Administration - Ve, 04/12/2020 - 23:13
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 3, 2020

Food and Drug Administration - Ve, 04/12/2020 - 00:05
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 1, 2020

Food and Drug Administration - Me, 02/12/2020 - 01:08
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

Food and Drug Administration - Ma, 01/12/2020 - 18:55
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

Food and Drug Administration - Lu, 30/11/2020 - 23:01
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

Food and Drug Administration - Me, 25/11/2020 - 20:39
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

Food and Drug Administration - Me, 25/11/2020 - 00:13
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First Drug to Treat Rare Metabolic Disorder

Food and Drug Administration - Ma, 24/11/2020 - 00:48
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

Food and Drug Administration - Lu, 23/11/2020 - 23:57
Coronavirus (COVID-19) Update, November 23, 2020
Categorie: Istituzioni

FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

Food and Drug Administration - Lu, 23/11/2020 - 18:59
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

Food and Drug Administration - Do, 22/11/2020 - 01:27
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

Food and Drug Administration - Sa, 21/11/2020 - 00:48
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

Food and Drug Administration - Ve, 20/11/2020 - 23:30
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

Food and Drug Administration - Ve, 20/11/2020 - 22:54
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
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