FDA
FDA issues priority review voucher for ISEMBYLD
FDA determined that ISEMBYLD (apitegromab-mstn), approved September 11, 2026 and manufactured by Scholar Rock, meets the criteria for a rare pediatric disease priority review voucher.
Read the official sourceFDA
FDA seeks comment on export certificate information collection
FDA opened a 60 day public comment opportunity concerning its proposed collection of information for export certificates covering FDA regulated products.
Read the official sourceMHRA
MHRA approves deuruxolitinib for severe alopecia areata
MHRA approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults and said it will keep the medicine’s safety and effectiveness under close review.
Read the official sourceMHRA
MHRA approves oral treatment for plaque psoriasis
MHRA announced approval of a new oral treatment for moderate to severe plaque psoriasis.
Read the official sourceWhy this matters
The voucher notice confirms application of FDA’s rare pediatric disease incentive framework, while the export certificate notice gives regulated companies an opportunity to comment on related information collection. The MHRA announcements add two UK authorization developments for regulatory teams tracking treatment availability and postapproval oversight.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.