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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples

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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

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

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

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

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

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

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

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

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

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

FDA Approves First Drug to Treat Rare Metabolic Disorder

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

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

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

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

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

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

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

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Gi, 19/11/2020 - 22:26
Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.
Categorie: Istituzioni

FDA Releases New Outbreak Investigation Table

Me, 18/11/2020 - 21:14
FDA releases new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Me, 18/11/2020 - 03:29
The FDA issued an emergency use authorization for the first COVID-19 diagnostic test that allows for self-collection and testing at home and provides test results in 30 minutes or less.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 17, 2020

Ma, 17/11/2020 - 23:26
Coronavirus (COVID-19) Update
Categorie: Istituzioni

COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

Ma, 17/11/2020 - 15:46
FDA is committed to transparency around the EUA process
Categorie: Istituzioni