https://www.jnj.com/media-center/press-releases/janssen-submits-supplemental-biologics-license-application-to-u-s-fda-seeking-approval-of-carvykti-for-the-earlier-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma
Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival...
biologics license applicationjanssensubmitssupplementalfda
https://www.biospace.com/bavarian-nordic-initiates-rolling-submission-of-biologics-license-application-with-fda-for-its-chikungunya-vaccine-candidate
Bavarian Nordic A/S (OMX: BAVA) today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a...
biologics license applicationbavarian nordicinitiatesrollingsubmission
https://www.wallstreet-online.de/nachricht/20307170-savara-resubmits-the-biologics-license-application-bla-to-the-u-s-food-and-drug-administration-fda-for-molbreevi-for-the-potential-treatment-of-autoimmune-pulmonary-alveolar-proteinosis-autoimmune-pap
22.12.2025 - Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced today that it...
biologics license applicationsavarablau
https://www.globenewswire.com/news-release/2025/11/07/3184018/0/en/Vera-Therapeutics-Submits-Biologics-License-Application-to-U-S-FDA-through-Accelerated-Approval-Program-for-Atacicept-for-the-Treatment-of-Adults-with-IgA-Nephropathy.html
Vera Therapeutics Submits BLA to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgAN...
biologics license applicationveratherapeuticssubmits
https://www.merck.com/news/fda-accepts-supplemental-biologics-license-application-assigns-priority-review-and-grants-breakthrough-therapy-designation-to-mercks-keytruda-pembrolizumab-for-first-line-treatment-o/
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority...
biologics license applicationpriority reviewfdaacceptssupplemental