OR WAIT null SECS
June 30, 2025
Article
Discover groundbreaking FDA approvals in 2025 that redefine treatment standards, enhance patient care, and address critical public health needs.
The CRL cited deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC, and the Company plans to request a Type A meeting.
June 27, 2025
We spotlight 7 impactful regulatory decisions scheduled to occur during the second half of 2025.
A form of the cytisine regimen, widely used in Eastern Europe for decades, is finally being put in front of US regulators after recently also becoming available in the UK.
June 24, 2025
With the approval, children ≥ 5 years of age with active lupus nephritis will have a first-of-its-kind treatment option for at-home administration.
June 21, 2025
Hereditary hemorrhagic telangiectasia has no approved treatments; this designation, in addition to the European Medicines Agency granting a positive opinion, positions DIAG723 to be the first.
June 20, 2025
This update by FDA officials extends the review period for ruxolitinib cream as a treatment for atopic dermatitis in children aged 2-11 years.
Nitisinone is the first and only FDA-approved treatment for AKU, a rare genetic disease without a known cure.
Dupilumab (Dupixent) approved as the first targeted therapy for bullous pemphigoid, marking 8th indication for diseases with type 2 inflammation.
June 19, 2025
With the FDA acceptance of the NDA, the agency has assigned a PDUFA target action date of January 31, 2026, and may require an Advisory Committee meeting for approval.
