These INDs include the EBVALLO TM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant ...

The clinical hold by the FDA is on active investigational new drug applications for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) treatment Ebvallo (tabelecleucel ...

Today, a brief rundown of news involving Intellia Therapeutics and ArriVent BioPharma, as well as updates from Atara Biotherapeutics, Amylyx Pharmaceuticals and InnoCare Pharma that you may have ...

days after rejecting its lead candidate Ebvallo (tabelecleucel). The Thousand Oaks, California-based biotech said that the clinical hold relates to compliance issues at a third-party manufacturing ...

FDA places a clinical hold on Atara's EBVALLO and ATA3219 programs due to GMP compliance issues at a third-party facility. Atara to pause new participant enrollment; CAR-T programs may suspend in ...

These INDs include the EBVALLO TM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant ...

Screening and enrollment of new participants in both programs have been paused. The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the ...

U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL) Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell ...

Screening and enrollment of new participants in both programs have been paused. The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during ...

Atara on Tuesday announced that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo in Epstein-Barr virus positive post ...

These INDs include the EBVALLO TM (tabelecleucel ... and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of ...

These INDs include the Ebvallo program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative ...