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FDA Alerts

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fda alert
FDA Approves Novel Treatment for Menopausal Hot Flashes
06/07/2023

Leigh Precopio

Leigh Precopio
The US FDA recently approved a novel treatment for moderate to severe vasomotor symptoms that are caused by menopause.
06/07/2023
FDA Alert
fda alert
FDA Alert
First Oral Treatment to Prevent Recurring Clostridioides difficile Infection Approved
06/01/2023

Jessica Ganga

Jessica Ganga
The FDA has approved the first orally administered treatment for the gut infection—clostridioides difficile.
06/01/2023
FDA Alert
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FDA Alert
FDA Approves First Prescription Nasal Spray to Reverse Opioid Overdose
05/27/2023

Jessica Ganga

Jessica Ganga
The FDA’s approval of nalmefene hydrochloride nasal spray marks the first of its kind for health care and community use.
05/27/2023
FDA alert
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FDA alert
First Oral Treatment Approved to Treat Moderate, Severe Crohn Disease
05/25/2023

Jessica Ganga

Jessica Ganga
After clinical trials to assess the safety, efficacy, and maintenance use, the FDA has approved the first oral treatment for moderately to severely active Crohn disease.
05/25/2023
FDA Alert
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FDA Alert
FDA Approves First Treatment of Agitation in Patients With Alzheimer Dementia
05/15/2023

Jessica Ganga

Jessica Ganga
Following two 12-week studies, the FDA has approved the first ever medication for treating agitation in patients with dementia due to Alzheimer disease.
05/15/2023
FDA alert
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FDA alert
FDA Approves the First RSV Vaccine For Use in United States
05/04/2023

Jessica Ganga

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 ALERT
medication
FDA ALERT
FDA Approves First Treatment for Rare, Degenerative Disease
04/18/2023

Jessica Ganga

Jessica Ganga
The FDA has approved a treatment for Friedreich ataxia after the results of randomized, placebo-controlled study indicate a strong effectiveness in treatment.
04/18/2023
FDA Alerts
FDA Alerts
FDA Approves Over-The-Counter Naloxone Spray for Opioid Overdoses
04/03/2023

Jessica Ganga

Jessica Ganga
The FDA approves the overdose medication for over-the-counter use after data supports its safe use.
04/03/2023
Enzyme Replacement Therapy
Enzyme Replacement Therapy
First Enzyme Replacement Therapy to Treat Rare Genetic Disorder Approved
03/17/2023

Jessica Ganga

Jessica Ganga
Following a multicenter study, the FDA has approved the first enzyme replacement therapy in the United States to treat alpha-mannosidosis.
03/17/2023
FDA alert
FDA
FDA alert
FDA Approves First Oral Treatment for CKD-Caused Anemia for Adults on Dialysis
02/08/2023
The FDA approves the first-of-its-kind treatment for anemia caused by CKD for adults who receive dialysis following the results of a randomized clinical trial.
02/08/2023