Rheumatology

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FDA issues CRL for apitegromab for SMA, citing facility inspection | Image Credit: Contemporary Pediatrics
FDA issues CRL for apitegromab for SMA, citing facility inspection

September 23rd 2025

Observations were not specific to apitegromab, and the CRL did not cite any other approvability concerns related to efficacy and safety data.

FDA approves tocilizumab-anoh for CRS in patients 2 years and older | Image credit: Contemporary Pediatrics
FDA approves tocilizumab-anoh for CRS in patients 2 years and older

August 6th 2025

Marstacimab reduces ABR in patients 12 years and up with hemophilia A or B with inhibitors | Image Credit: © lexiconimages - © lexiconimages - stock.adobe.com.
Marstacimab reduces ABR in patients 12 years and up with hemophilia A or B with inhibitors

June 26th 2025

FDA will not meet original PDUFA data for sebetralstat to treat HAE | Image Credit: Contemporary Pediatrics
FDA will not meet original PDUFA date for sebetralstat to treat HAE

June 16th 2025

Positive data: Navepegritide, lonapegsomatropin combination treatment for children with achondroplasia | Image Credit: © lexiconimages - © lexiconimages - stock.adobe.com.
Positive data: Navepegritide, lonapegsomatropin combination treatment for children with achondroplasia

June 9th 2025

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