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
FDA Grants Priority Review to KEYTRUDA + SOC as Perioperative Treatment for Resectable Locally Advanced SCCHN; PDUFA: Jun 23, 2025 March 4, 2025
FDA RMAT Designation for CAR-NK in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer March 4, 2025
Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable NSCLC March 4, 2025
Enhertu recommended for approval in the EU by CHMP for patients with HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy March 4, 2025
DARZALEX® (daratumumab) SC-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility March 4, 2025
Jaypirca (pirtobrutinib) recommended by CHMP for approval in the EU for adults with R/R CLL previously treated with a BTKi March 4, 2025
Zongertinib receives Priority Review from US FDA for the treatment of HER2-mutant advanced NSCLC February 25, 2025
