Findings from HERTHENA-Lung02 showed that the key secondary endpoint of overall survival did not meet statistical significance.

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) seeking approval for its COVID-19 and Influenza combination vaccine for ...

today confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host ...

Savara (NASDAQ:SVRA) announced Tuesday its plans to meet with the U.S. FDA after the regulator issued a refusal to file (RTF) ...

Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE ® FL-1 trial Full results from the trial will be ...

The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for ...

Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688 ...