June 12th 2023
If approved, nirsevimab would be the first immunization specifically to protect infants through their first RSV season. The Prescription Drug User Fee Act date is in the third quarter of 2023.
February 9th 2023
Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.
January 5th 2023
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
January 4th 2023
Wegovy is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.
December 17th 2022
If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.
FDA Grants Six Months Pediatric Exclusivity for Eylea
Eylea is being reviewed as a treatment for retinopathy in premature infants.
FDA Uses Real-World Data to Approve Boostrix for Prevention of Infection in Infants
Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.
FDA Accepts NDA for Rett Syndrome Drug
If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.
Tris Pharma Launches Dyanavel XR Tablets for ADHD
A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.
FDA Approves Xofluza to Treat and Prevent Flu in Children
Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.
FDA Extends Review of Omaveloxolone in Friedreich’s Ataxia
The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.
FDA Approves Stelara in Children with Psoriatic Arthritis
Stelara is the first biologic targeting both cytokines IL-12 and IL-23 and offers a therapeutic option for children six years of age and older living with active psoriatic arthritis, a rare disease.
FDA Approves Dupixent for Young Children with Atopic Dermatitis
Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.
FDA Extends Review Time for Pompe Disease Therapy
The FDA needs more time to assess information submitted by the company.
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
Concerns About Childhood COVID-19 Vaccines Persist, Despite FDA Committee OK
Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.
FDA Approves Dupixent for Children with Asthma
Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.
FDA Approves First Therapy for Rare Immune Disorder
Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.
Janssen Submits Application for Stelara for Psoriatic Arthritis in Children
An FDA decision is expected in late 2022.
Sanofi Selects Orsini as Limited Distribution Partner for Nexviazyme
The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.
FDA has Accepted Application for Rare Epilepsy
The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.
Merck Vaccine and Other FDA Updates
Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
New ADHD Treatment is Now Available
Azstarys is approved to treat patients 6 years and older.
Novartis defends data on its $2.1 million drug
While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.
Pharma maker expands ibuprofen recall
Pharma makers recall 2 important drugs
Two major drug recalls in the last week include an expanded recall of a widely used blood pressure medication as well as over-the-counter infant ibuprofen.
FDA wants certain OTC teething gels off the market
FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.
Training, advising pediatricians in antibiotic usage improves compliance with prescription guidelines
Educating pediatricians in their offices, auditing their prescription patterns, and leveraging a shared electronic health record, encourages them to choose more appropriate antibiotics for children with common respiratory infections, according to a study published in the June 12 issue of the Journal of the American Medical Association.
Newer whooping cough vaccines less effective than older vaccines
Teenagers who received DTaP (acellular pertussis vaccine) in their first 2 years of life had a 6 times higher risk of contracting pertussis compared with those who received DTwP (whole-cell pertussis vaccine) in their first 2 years of life, according to a study online in Pediatrics.
AAP publishes guidelines for managing pediatric C difficile infections
The American Academy of Pediatrics (AAP) has published a policy statement to provide pediatricians with recommendations for assessing and treating Clostridium difficile infections (CDI) in children.
2012 vaccination schedules published for children, adults
The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.
FDA Actions in Brief January 2012 (Antares, Isentress, REMS)
Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)
Children’s research discovery aids in adult cancer drug development
The recent approval by FDA of an adult cancer therapy is 1 example of how children’s cancer research benefits patients of all ages.
Topiramate reclassified as Category D due to potential link to oral clefts in newborns
FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.
Birth defects risk appears low with newer-generation antiepileptics
First-trimester exposure to antiepileptic drugs compared with no exposure does not appear to increase the risk of major birth defects, according to a Danish study, published in the May 18 issue of the Journal of the American Medical Association.
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