Clinical

Articles

Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.

Concerns About Childhood COVID-19 Vaccines Persist, Despite FDA Committee OK

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.



FDA Approves Dupixent for Children with Asthma

Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.

FDA Approves First Therapy for Rare Immune Disorder


An FDA decision is expected in late 2022.


Janssen Submits Application for Stelara for Psoriatic Arthritis in Children

The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.

Sanofi Selects Orsini as Limited Distribution Partner for Nexviazyme

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.


FDA has Accepted Application for Rare Epilepsy

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

Merck Vaccine and Other FDA Updates

Azstarys is approved to treat patients 6 years and older.

New ADHD Treatment is Now Available

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.

Pediatrics