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FDA Alerts

FDA ALERT
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FDA ALERT
FDA Approves Nedosiran for Patients 9 Years of Age and Older With Primary Hyperoxaluria Type 1
01/29/2024
Anthony Calabro, MA
The once-monthly RNA interference injection medication received FDA approval based on results from the phase II PHYOX2 clinical trial and phase III PHYOX3 extension study.
01/29/2024
FDA ALERT
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FDA ALERT
FDA Approves Interchangeable Biosimilar for Psoriatic Arthritis, Other Inflammatory Conditions
11/30/2023
Anthony Calabro, MA
The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.
11/30/2023
FDA Alert
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FDA Alert
Tirzepatide Gains FDA Approval for Chronic Weight Management
11/13/2023
Tirzepatide is now approved for a new indication. The dual GIP/GLP-1 agonist was previously approved for treating type 2 diabetes in May 2022.
11/13/2023
FDA Alert
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FDA Alert
Second OTC Naloxone Nasal Spray Approved by FDA
09/28/2023
Anthony Calabro, MA
The FDA approved the second over-the-counter nasal spray with the goal of increasing access to products that can rapidly reverse the effects of opioid overdose.
09/28/2023
FDA Alert
fda alerts
FDA Alert
As Infections Increase, FDA Approves Updated Vaccines to Protect Against COVID-19 Variants
09/15/2023
Anthony Calabro, MA
The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.
09/15/2023
FDA alert
fda alert
FDA alert
New Treatment for Certain Bacterial Pneumonia Approved by FDA
08/25/2023
Jessica Ganga
Following a multicenter clinical trial, a new treatment for pneumonia caused by Acinetobacter baumannii-calcoaceticus has been approved for use in adults.
08/25/2023
FDA Alert
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FDA Alert
FDA Approves First RSV Vaccine For Pregnant Individuals
08/24/2023
Anthony Calabro, MA
Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
08/24/2023
FDA alert
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FDA alert
FDA Approves the First RSV Vaccine For Use in United States
05/04/2023
Jessica Ganga
After an ongoing study, the FDA approves the first vaccine for the highly contagious respiratory virus for us in the United States.
05/04/2023
FDA Alerts
FDA Alerts
FDA Approves Over-The-Counter Naloxone Spray for Opioid Overdoses
04/03/2023
Jessica Ganga
The FDA approves the overdose medication for over-the-counter use after data supports its safe use.
04/03/2023
FDA ALERT
fda
FDA ALERT
FDA Approves Interchangeable Biosimilar for Psoriatic Arthritis, Other Inflammatory Conditions
11/08/2015
Anthony Calabro, MA
The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.
11/08/2015