The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS
16 Dec 2022 //
GLOBENEWSWIRE
U.S. FDA declines to approve Y-mAbs`s pediatric cancer drug
02 Dec 2022 //
HEALTH ET
Y-mAbs Announces Complete Response Letter for Omburtamab BLA
01 Dec 2022 //
GLOBENEWSWIRE
Y-mAbs` rare disease drug roundly rejected by FDA AdComm over weakness
01 Nov 2022 //
FIERCEBIOTECH
Y-mAbs Announces Outcome of FDA Advisory Committee Meeting on Omburtamab
29 Oct 2022 //
GLOBENEWSWIRE
Y-mAbs Announces Pivotal Data for Omburtamab
03 Oct 2022 //
GLOBENEWSWIRE
FDA Accepts Y-mAbs` BLA for OMBLASTYS for Neuroblastoma for Priority Review
31 May 2022 //
GLOBENEWSWIRE
Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA
01 Apr 2022 //
GLOBENEWSWIRE
Y-mAbs Provides Regulatory Update on Omburtamab for Neuroblastoma Metastasis
04 Nov 2021 //
GLOBENEWSWIRE
Y-mAbs Takeda Announce Exclusive License and Distribution Agreement
04 Dec 2020 //
STREETINSIDER
Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab
26 Oct 2020 //
BIOSPACE
FDA hands Y-mAbs refusal to file letter in one of its pediatric neuroblastoma
07 Oct 2020 //
ENDPTS
Y-mAbs Announces Initiation of Submission of Omburtamab Rolling BLA to the FDA
30 Jun 2020 //
GLOBENEWSWIRE
Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab
26 Feb 2020 //
GLOBENEWSWIRE
Y-mAbs Secures Commercial Radiolabeling Capacity
03 Jul 2019 //
CONTRACT PHARMA