Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
Tempest Therapeutics, Inc. bets on dual-targeting CAR-T to address antigen escape challenges
Tempest Therapeutics, Inc. advances TPST-2003 CAR-T data. Discover how dual-targeting could impact multiple myeloma treatment durability.
What Tempest Therapeutics, Inc.’s CAR-T strategy reveals about the next phase of cell therapy competition
Find out how Tempest Therapeutics, Inc.’s CAR-T strategy could shape the next phase of cell therapy competition and multiple myeloma innovation.
Why Gilead’s Arcellx acquisition approval could reshape the multiple myeloma CAR-T race
Gilead has cleared regulatory hurdles for Arcellx. Read why the anito-cel takeover could reshape the multiple myeloma CAR-T market.
Johnson & Johnson strengthens its multiple myeloma franchise with TECVAYLI and DARZALEX FASPRO approval. What clinicians are watching next
FDA approves TECVAYLI plus DARZALEX FASPRO for relapsed multiple myeloma. Discover what the MajesTEC-3 data means for future immunotherapy strategies.
J&J’s Tecvayli-Darzalex Faspro combination approved for myeloma after MajesTEC-3 Phase 3 results
FDA approves J&J’s teclistamab plus daratumumab for relapsed myeloma from second line. Analyse the MajesTEC-3 data, safety profile, and what this changes for treatment.
Why Gilead Sciences’ Arcellx acquisition reshapes the competitive dynamics of BCMA CAR T therapy
Gilead Sciences’ acquisition of Arcellx signals a strategic shift in CAR T therapy control and scale. Find out what it changes for multiple myeloma.
Starton Therapeutics advances STAR-LLD as delivery innovation in multiple myeloma
Starton Therapeutics advances STAR-LLD in Phase 2a. Explore how continuous lenalidomide delivery could reshape multiple myeloma care.
Bristol Myers Squibb pushes CELMoD frontier as FDA accepts iberdomide NDA in relapsed multiple myeloma
FDA accepts Bristol Myers Squibb’s iberdomide NDA for relapsed multiple myeloma. Find out what this CELMoD filing could change next.
Johnson & Johnson expands DARZALEX FASPRO label with new D-VRd approval in newly diagnosed myeloma
Find out how DARZALEX FASPRO’s FDA approval for transplant-ineligible myeloma patients could shift frontline treatment standards.