FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials

Bristol Myers Squibb unveils breakthrough Lymphoma data

Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas

Imugene reports strong early results for Azer-cel in aggressive blood cancer trial

Data deluge at ASH: Bristol Myers Squibb showcases breakthroughs across blood cancers

Fresh Phase 1b/2a data highlight the strength of the iberdomide + daratumumab + dexamethasone combination in transplant-deferred or ineligible NDMM

EU clears Bristol Myers Squibb’s CAR-T therapy Breyanzi for tough-to-treat Lymphoma

The European Commission’s green light marks Breyanzi’s fourth indication in Europe and extends access to patients across all EU and EEA countries

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access

FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL

Approval is based on positive data from the Phase 3 ECHELON-3 trial

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma

EC approves Ordspono for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma

Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission