FDA Clears IND Application for Ph 1 Trial of RB-164 for Hematologic and Solid Malignancies April 2, 2025
US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma April 2, 2025
Positive CHMP Opinion for Neoadjuvant Opdivo + Chemo Followed by Surgery and Adjuvant Opdivo for Resectable NSCLC in Patients with Tumor Cell PD-L1 Expression ≥1% April 2, 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP for 1L MCL April 2, 2025
FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient March 26, 2025
Second DSMB Issues Positive Recommendation to Continue Bria-IMT Ph 3 Study in Metastatic Breast Cancer March 26, 2025
FDA Clears IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic CRC March 18, 2025
Update relating to Resminostat’s (Kinselby) Marketing Authorisation Application announced March 18, 2025
EU authorises CTA to initiate VIDAR-1 Ph 1/2 umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer March 18, 2025
U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia March 18, 2025
Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) ALL March 11, 2025
FDA accepts Supplemental BLA for Opdivo + Yervoy for Patients with Unresectable or Metastatic MSI-H or MRD CRC March 4, 2025
FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer March 4, 2025