The FDA accepted Bristol Myers Squibb’s NDAs for iberdomide and mezigdomide, two CELMoD agents for relapsed/refractory multiple myeloma. Iberdomide has Priority Review and a PDUFA date of Aug. 17, 2026; mezigdomide’s is May 13, 2027. The filings are backed by Phase 3 data, including a 52% PFS risk reduction for mezigdomide.
The Lancet refused a U.S. Senate request for evidence on COVID-19 origins. Purdue Pharma's sentencing was delayed, while insurers moved to reduce prior-authorization paperwork.
Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.
A phase 3 clinical trial has launched for pridopidine as a potential ALS treatment, while AI research identified 18 FDA-approved drugs that may extend survival. Separate studies found a promising three-drug combination for sporadic ALS using new cell models.
