FDA Accepts Odronextamab Lymphoma Drug Resubmission

FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after phase 3 trial enrollment milestone.
Regeneron gets FDA Review acceptance for odronextamab's resubmitted BLA
Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the U.S. FDA has accepted its resubmitted Biologics License Application for odronextamab, a treatment for patients with relapsed or refractory follicular lymphoma who have undergone at least two prior therapies.
Odronextamab BLA resubmission accepted for FDA review
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Regeneron announces FDA accepted for review BLA for odronextamab
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for review the resubmission of the
Regeneron: FDA Accepts Odronextamab Lymphoma Drug Resubmission
Regeneron last year won European Commission approval of odronextamab as Ordspono for relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy. Write to Colin Kellaher at [email protected]
Cure Today8d
The Good and The Bad of Follicular Lymphoma
My annual scan showed no cancer recurrence, but revealed some minor issues related to aging and potential fibroids, requiring ...
Healio17h
Gazyva significantly boosts complete renal response rates in active lupus nephritis
Adding obinutuzumab to standard therapy for active lupus nephritis led to significantly higher rates of complete renal ...
Crain's Chicago Business1d
A mixed bag for Tempus AI despite 'fantastic' quarter
Despite optimistic news from the CEO yesterday afternoon, the company's shares fell overnight and a major investment house ...
Hosted on MSN7d
Why Tempus AI (TEM) Crashed on Tuesday?
In a statement, Tempus AI (NASDAQ:TEM) said it partnered with the Institute for Follicular Lymphoma Innovation (IFLI) to ...