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
Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T) for Advanced Ovarian Cancer February 11, 2025
Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Announced February 11, 2025
All clinical studies evaluating TIDAL-01 to discontinue and further development of the program halted February 11, 2025
US FDA Grants Orphan Drug Designation to 225Ac-SSO110 (satoreotide) for the treatment of patients with SCLC February 11, 2025
FDA feedback provided on potential ELI-002 Ph 3 study design, including dose, schedule, patient population and primary endpoint analysis January 28, 2025
BLA accepted, Priority Review granted for RP1 for the Treatment of Advanced Melanoma January 28, 2025
