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
Petosemtamab granted Breakthrough Therapy designation by the US FDA for 1L PD-L1 positive head and neck squamous cell carcinoma February 25, 2025
US FDA grants Fast Track Designation to Cu-67 SAR-bisPSMA for the treatment of metastatic CRPC patients February 25, 2025
FDA Acceptance and Priority Review of NDA for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma February 25, 2025
Linvoseltamab BLA Accepted for FDA Review for the Treatment of R/R Multiple Myeloma; PDUFA: 10Jul2025 February 19, 2025
FDA Fast Track Designation for CUSP06 for the Treatment of Platinum-Resistant Ovarian Cancer February 19, 2025
Fast Track Designation granted from the U.S. FDA for Amezalpat to Treat Patients with HCC February 19, 2025
Positive FDA Guidance Received for Acceleration of Registration-Enabling MIRACLE Trial for R/R AML February 19, 2025
