GlobalData on MSN

Atara receives FDA complete response letter for Ebvallo BLA application

The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.

Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2…

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that it has submitted a Biologics ...
Zacks Investment Research on MSN

CAPR updates FDA on Deramiocel BLA, plans HOPE-3 CSR filing in February

Capricor Therapeutics CAPR recently provided a regulatory update on its Biologics License Application (BLA) for Deramiocel, ...
Neurology Advisor

Valneva Withdraws Chikungunya Vaccine BLA After FDA Suspension

Valneva has made the decision to withdraw the Biologics License Application for its chikungunya vaccine Ixchiq®.

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates ...

ImmunityBio shares climb as bladder cancer trial nears full enrollment, BLA submission expected by year-end

ImmunityBio’s IBRX QUILT-2.005 trial tops enrollment forecasts; BLA filing targeted by year-end after positive ANKTIVA+BCG ...
Cartoon Brew

“Bla Bla”, An Interactive Short by Vincent Morisset

UPDATE: MARCH 15, 2012: Bla Bla won the SXSW Interactive Award. Is it a film or a game? Interactivity and non-linear storytelling have been more the realm of gaming than short filmmaking, but the two ...