Pediatrics

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FDA Alerts

FDA Alert
vaccine
FDA Alert
FDA Approves First Monoclonal Injection to Prevent RSV in Infants, Toddlers
07/24/2023
Jessica Ganga
Following three clinical trials, the FDA has approved a new preventive treatment for neonates, infants, and toddlers that prevents respiratory syncytial virus (RSV) in those age populations.
07/24/2023
FDA Alert
Child holding stomach
FDA Alert
First Treatment for Pediatric Functional Constipation Approved by FDA
06/15/2023
Jessica Ganga
The FDA approved the first treatment for pediatric patients who experience functional constipation
06/15/2023
FDA ALERT
medication
FDA ALERT
FDA Approves First Treatment for Rare, Degenerative Disease
04/18/2023
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
Enzyme Replacement Therapy
Enzyme Replacement Therapy
First Enzyme Replacement Therapy to Treat Rare Genetic Disorder Approved
03/17/2023
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
Treatment
Treatment
FDA Approves First Treatment for Active Psoriatic Arthritis in Pediatric Patients
08/23/2022
The US Food and Drug Administration has approved a new treatment for pediatric patients with active psoriatic arthritis.
08/23/2022
Pediatrics
Pediatrics
FDA Approves New ADHD Treatment Option for Children
04/07/2021
The US Food and Drug Administration has approved a new nonstimulant drug for the treatment for attention-deficit/hyperactivity disorder in children.
04/07/2021
Pediatrics
Pediatrics
FDA Approves First Video Game-Based Treatment for ADHD
06/17/2020
The US Food and Drug Administration has approved the marketing of the first video game-based digital therapeutic device for the treatment of children aged 8 to 12 years with attention deficit hyperactivity...
06/17/2020
smoking
smoking
FDA Releases Enforcement Policy For Flavored E-Cigarettes
01/03/2020
The Food and Drug Administration (FDA) has issued an enforcement policy on the manufacturing and distribution of unauthorized flavored e-cigarette products that appeal to children.
01/03/2020
peanut allergy
peanut allergy
FDA Panel Recommends Approval of First Therapy for Peanut Allergy
09/16/2019
An FDA advisory committee has recommended the approval of the first therapy for peanut allergies.
09/16/2019
FDA
FDA
FDA Approves First Gene Therapy in the US
08/30/2017
The FDA has approved the first CAR T-cell therapy available in the United States for the treatment of certain pediatric patients.
08/30/2017