The revision follows concerns related to the delayed approval of Atara's Ebvallo and the possibility that the company may discontinue its CAR-T development in the first quarter of 2025.

The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO. The CRL did not identify any deficiencies related to ...

Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as monotherapy treatment for adult and pediatric patients ...

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 ...

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 ...

As partners Atara Biotherapeutics and Pierre Fabre Laboratories work to grow the reach of their novel T-cell immunotherapy Ebvallo, a manufacturing-related hitch has tripped up their ambition to ...

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 ...

Atara disclosed these specifics in their release. Already authorized in the European Union,EBVALLO is based on data from the key ALLELE trial. According to Atara's announcement, the study revealed ...

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 ...

Atara Biotherapeutics (NASDAQ:ATRA) has announced plans to cut around 50% of its workforce, just a little over a week after it said the FDA had declined to approve its immunotherapy Ebvallo.