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ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against the company’s biologics license application (BLA) seeking approval of lead ...
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Atara’s T cell programmes hit with clinical hold after third-party site woes
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 ...
Atara Biotherapeutics: Another Dip Buying Opportunity Following CRL For CMC Issues
Atara Biotherapeutics has just announced a CRL by FDA for EBVALLO. Click here to read more about ATRA stock and why it is rated as a Buy.
FiercePharma16d
Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
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 ...
FiercePharma21d
Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls
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 ...
BioSpace15d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a ...
Business Wire21d
Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLO TM (tabelecleucel)
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 ...
Business Insider21d
Atara announces Ebvallo CRL did not find clinical efficacy deficiencies
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 ...
Atara Biotherapeutics reports clinical hold placed on Ebvallo programs, ATA3219
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND, ...
Atara to cut 50% of workforce amid FDA woes
Atara Biotherapeutics (ATRA) plans to cut around 50% of its workforce, just a little over a week after the FDA declined to ...
Yahoo Finance16d
Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219
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 ...
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Atara Biotherapeutics Sees Its Share Price Fall
Atara Biotherapeutics experiences a plunge in share prices after the Food and Drug Administration holds up approval of a drug ...