Mezigdomide for Relapsed/refractory multiple myeloma
The FDA is expected to decide on Mezigdomide for Relapsed/refractory multiple myeloma by May 13, 2027, under a NDA from Bristol Myers Squibb.
What is being decided
Bristol Myers Squibb has a NDA under FDA review for Mezigdomide in Relapsed/refractory multiple myeloma. Oral CELMoD agent for heavily pretreated multiple myeloma.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
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Frequently asked questions
When will the FDA decide on Mezigdomide?
The FDA's target decision date (PDUFA date) for Mezigdomide in Relapsed/refractory multiple myeloma is May 13, 2027, disclosed by Bristol Myers Squibb. The agency can act before this date and occasionally runs past it.
What is Mezigdomide being reviewed for?
Bristol Myers Squibb submitted a NDA for Mezigdomide in Relapsed/refractory multiple myeloma. Oral CELMoD agent for heavily pretreated multiple myeloma.
What happens after the Mezigdomide decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from BMS press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.