It closed at $6.93 on Jan. 23. Preceding the sharp decline was the Food and Drug Administration releasing a letter to the company stating concerns about the third-party manufacturer of its blood ...
Preceding the sharp decline was the Food and Drug Administration releasing a letter to the company stating concerns about the third-party manufacturer of its blood cancer drug Ebvallo and delaying ...
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.
This decision comes in the wake of the Food and Drug Administration's (FDA) Complete Response Letter (CRL) regarding Atara's EBVALLO application and the subsequent halt of several clinical trials.
This decision comes in the wake of the Food and Drug Administration's (FDA) Complete Response Letter (CRL) regarding Atara's EBVALLO application and the subsequent halt of several clinical trials.
Atara announced on January 16, 2025, that it had received "a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLO TM (tabelecleucel) Biologics License ...
According to the Company, "The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO." If you are a shareholder ...
According to Atara, "The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO." What's Next? If you are aware of ...
The Company stated that "[t]he CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO." Following this news ...