Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

ByRidhi RastogiAugust 24, 2026

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BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

Shots: FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd;…

ByRidhi RastogiAugust 14, 2026

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BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Shots: The US FDA has accepted NDA of mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027) NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd…

ByRidhi RastogiJuly 13, 2026

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The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Shots: The US has approved Sarclisa Escena (isatuximab-irfc; SC) + SoC for the treatment of pts with MM across all existing indications of Sarclisa IV formulation Approval was backed by multiple trials, incl. P-III (IRAKLIA) in R/R MM, which showed shorter treatment time & fewer infusion-related reactions with Sarclisa Escena In IRAKLIA, SC Sarclisa delivered…

ByRidhi RastogiJuly 13, 2026

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The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Shots: The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review Approval was based on the P-III (IRAKLIA) study in R/R…

ByRidhi RastogiJune 19, 2026

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Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Shots: Pfizer has reported the P-III (MagnetisMM-5) trial data assessing Elrexfio monotx. (SC) vs daratumumab + pomalidomide & dexamethasone for the treatment of adults (n= 497) with r/r MM who received prior ≥1L of treatment Trial met its 1EP of improved PFS, as assessed by BICR, while OS data (2EP) remain immature & is under assessment; data…

ByRidhi RastogiMay 1, 2026

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TJ Biopharma Licenses Felzartamab to Biogen for Greater China in ~$850M Deal

Shots: TJ Bio has granted Biogen exclusive rights to felzartamab in Greater China, giving Biogen full global ownership as the drug advances through P-III trials across multiple immune-mediated diseases As per the deal, TJ Bio will receive $100M upfront, with ~$750M in commercial & sales milestones, plus mid-single to low-double-digit % of royalties on Greater…

ByRidhi RastogiApril 21, 2026

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Eli Lilly to Acquire Kelonia Therapeutics for ~$7B

Shots: Eli Lilly has entered into a definitive agreement to acquire Kelonia Therapeutics, expanding Lilly’s genetic medicine capabilities As per the deal, Lilly will acquire Kelonia for ~$7B in cash, incl. $3.25B upfront, & additional clinical, regulatory & commercial milestone payments; closing expected in H2’26 Acquisition will add Kelonia’s in vivo gene placement system (iGPS0) & its lead asset, KLN-1010, a one-time IV…

ByRidhi RastogiApril 21, 2026

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Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Shots: The EMA has received the Type II variation application for Tecvayli monotx. (teclistamab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Application was supported by the P-III (MajesTEC-9) trial assessing Tecvayli vs SoC of pomalidomide, bortezomib, & dexamethasone (PVd) or carfilzomib & dexamethasone (Kd) in 614…

ByRidhi RastogiMarch 12, 2026

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Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

Shots: The US FDA has approved Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab & hyaluronidase-fihj) for the treatment of adults with r/r MM, who have received ≥1L of prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent Approval was based on the ongoing P-III (MajesTEC-3) study evaluating Tecvayli + Darzalex vs investigator’s choice of Darzalex & dexamethasone with…

ByRidhi RastogiMarch 6, 2026

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

TJ Biopharma Licenses Felzartamab to Biogen for Greater China in ~$850M Deal

Eli Lilly to Acquire Kelonia Therapeutics for ~$7B

Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

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