FDA Alerts

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
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fda alert
FDA Approves Two New Uses of Quizartinib for Acute Myeloid Leukemia
10/19/2023
Leigh Precopio
The FDA approved the use of quizartinib for certain patient populations with acute myeloid leukemia in July 2023.
10/19/2023
FDA Alert
Fda alert
FDA Alert
FDA Approves First Oral Medication for Treatment of Postpartum Depression
10/04/2023
Jessica Ganga
Following two randomized studies, the FDA has approved zuranolone for the treatment of postpartum depression in adults—the first if its kind.
10/04/2023
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
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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
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FDA Alert
FDA Approves Liver-Directed Treatment for Adults With Metastatic Uveal Melanoma
09/11/2023
Anthony Calabro, MA
The FDA approval follows a single-arm, multicenter, open-label trial in 91 patients with uveal melanoma with unresectable hepatic metastases.
09/11/2023
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
FDA Alert
FDA Alert
FDA Approves Two Medications to Treat Pediatric Patients With Type 2 Diabetes
08/10/2023
Jessica Ganga
The FDA has approved empagliflozin, and empagliflozin and hydrochloride to help manage type 2 diabetes in pediatric patients.
08/10/2023
FDA Alert
Fda alert
FDA Alert
FDA Approves New Treatment Option for People With Opioid Use Disorder
08/01/2023
Jessica Ganga
The FDA has approved a new buprenorphine treatment option for people with opioid use disorder following clinical trials that tested its safety and efficacy.
08/01/2023