Upfront fees and near-term development milestone payments totaling up to $11 millionSales milestones of $150 million or more ...

Agenus will give Zydus an exclusive licence for the development and commercialisation of BOT and BAL in Sri Lanka and India.

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

HCW Biologics earned upfront payment and will recognize revenue of $7.0 million in Q2 2025MIRAMAR, Fla., June 04, 2025 (GLOBE ...

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 ...

(RTTNews) - The Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan, co-developed by Merck & Co Inc. (MRK) and Daiichi Sankyo Company, Limited (DSKYF ...

today announced that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denileukin diftitox (I/ONTAK), an engineered IL-2-diphtheria ...

Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Voluntarily Withdrawn The Biologics ...

Immatics (NASDAQ:IMTX) shares surged 11.7% after early trial results of IMA203 cell therapy showed a 56% response rate in ...

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 ...

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

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential ...