SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…

ByRidhi RastogiDecember 4, 2025

Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Shots: Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…

ByRidhi RastogiOctober 8, 2025

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Shots: The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s review Trial showed that SC is noninferior to IV in AUC…

ByRidhi RastogiMarch 28, 2025

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

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