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.

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 ...
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, ...
JD Supra

Biological Products Regulation Part 3: Unlocking Reference Product Exclusivity: What Sponsors Need to Know

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

Summit Therapeutics (SMMT) Is Down 8.7% After Ivonescimab BLA Filing And Oncology Expansion Update – Has The Bull Case Changed?

Summit Therapeutics has submitted a Biologics License Application to the FDA for ivonescimab, a first-in-class bispecific ...
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®.

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 ...
Targeted Oncology

FDA Receives BLA for Ivonescimab in EGFR+ NSCLC

The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...