# multiple myeloma (blogs) — RSS Amplifier Recent posts from the 2 feeds in the RSS Amplifier directory that cover multiple myeloma. Page: Feed: --- ## [Dr. Ying Huang presents first-in-human data for in vivo CAR-T LB2501 in B-cell NHL](https://sohoinsider.com/news/dr-ying-huang-presents-first-in-human-data-for-in-vivo-car-t-lb2501-in-b-cell-nhl/?utm_source=rss&utm_medium=rss&utm_campaign=dr-ying-huang-presents-first-in-human-data-for-in-vivo-car-t-lb2501-in-b-cell-nhl) _2026-08-21 · SOHO Insider Editors · SOHO Insider_ He explains how this in vivo lentiviral vector infusion aims to eliminate traditional manufacturing barriers by shifting the cell engineering process directly into the patient's body. The post Dr. Ying Huang presents first-in-human data for in vivo CAR-T LB2501 in B-cell NHL appeared first on SOHO Insider . ## [Lawmakers urge FDA to enact new China policies after 3 gene therapy deaths](https://www.biospace.com/policy/lawmakers-urge-fda-to-enact-new-china-policies-after-3-gene-therapy-deaths) _2026-08-21 · Gabrielle Masson · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Three fatalities occurring recently in China clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients. ## [Liso-cel plus ibrutinib induces deep remissions in patients with relapsed or refractory CLL/SLL](https://sohoinsider.com/news/liso-cel-ibrutinib-remissions-relapsed-refractory-cll-sll/?utm_source=rss&utm_medium=rss&utm_campaign=liso-cel-ibrutinib-remissions-relapsed-refractory-cll-sll) _2026-08-21 · Kerri Fitzgerald · SOHO Insider_ William G. Wierda, MD, of the University of Texas MD Anderson Cancer Center, and colleagues, published the findings in Blood. The post Liso-cel plus ibrutinib induces deep remissions in patients with relapsed or refractory CLL/SLL appeared first on SOHO Insider . ## [Regeneron wins FDA approval to challenge Ipsen for rare bone disease market](https://www.biospace.com/fda/regeneron-wins-fda-approval-to-challenge-ipsen-for-rare-bone-disease-market) _2026-08-20 · Nick Paul Taylor · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Regeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos. ## [Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision](https://www.biospace.com/fda/ultragenyx-bags-first-gene-therapy-approval-as-previously-rejected-sanfilippo-asset-awaits-decision) _2026-08-20 · Nick Paul Taylor · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently reviewing for a second time. A decision is expected by mid-September. ## [Partnership expands access to CLL treatment in low-, middle-income countries](https://sohoinsider.com/news/partnership-expands-access-to-cll-treatment-in-low-middle-income-countries/?utm_source=rss&utm_medium=rss&utm_campaign=partnership-expands-access-to-cll-treatment-in-low-middle-income-countries) _2026-08-20 · SOHO Insider Editors · SOHO Insider_ To date, the initiative has enabled access to the treatment for more than 300 patients across Armenia, Ethiopia, and Nepal, exceeding its original scope by about 150 patients. The post Partnership expands access to CLL treatment in low-, middle-income countries appeared first on SOHO Insider . ## [Why pediatric rare oncology outperforms in a volatile biotech market](https://www.biospace.com/drug-development/opinion-why-pediatric-rare-oncology-outperforms-in-a-volatile-biotech-market) _2026-08-20 · Paul Romness · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Real progress happens where unmet medical need is greatest and patient impact can be clearly measured. Pediatric rare cancers exemplify these criteria and have therefore generated continued investment, even in a capital-constrained environment. ## [Trump's FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: Analysts](https://www.biospace.com/fda/trumps-fda-pick-overton-good-for-psychedelics-new-pain-meds-but-bad-for-vaccines-analysts) _2026-08-19 · Heather McKenzie · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain drugs, but could tow the party line on vaccines. ## [Trump picks White House aide Heidi Overton as FDA chief: Reports](https://www.biospace.com/fda/trump-picks-white-house-aide-heidi-overton-as-fda-chief-reports) _2026-08-19 · Annalee Armstrong · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ If Heidi Overton clears the Senate nomination process, analysts say she will have a tough job ahead to “restore predictability” to an agency battered by layoffs and controversial policies. ## [Amylyx’s redemption story, Summit’s survival woes, Definium’s anxiety win, more](https://www.biospace.com/fda/amylyxs-redemption-story-summits-survival-woes-definiums-anxiety-win-more) _2026-08-19 · Jef Akst · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Amylyx shares good news for its investigational GLP-1 blocker; Definium announces positive data for its LSD-based therapy in anxiety; Summit/Akeso’s ivonescimab shows degrading survival benefits; patients treated with Neurocrine’s Prader-Willi drug experience serious adverse events; and Eli Lilly cracks down on the black market for next-gen obesity asset retatrutide. ## [Crush Every Threat in Real Time (Sponsored)](https://crawlproof.com/a/dvhkEMzNudBQ) _2026-08-19 · **Sponsored**_ One agent for real-time detection, exposure tracking, and active defense. ## [Phase 1 data reported for anti-CD123 CAR T-cell therapy in relapsed or refractory AML, BPDCN](https://sohoinsider.com/leukemia/phase-1-data-reported-for-anti-cd123-car-t-cell-therapy-in-relapsed-or-refractory-aml-bpdcn/?utm_source=rss&utm_medium=rss&utm_campaign=phase-1-data-reported-for-anti-cd123-car-t-cell-therapy-in-relapsed-or-refractory-aml-bpdcn) _2026-08-19 · Patrick Daly · SOHO Insider_ The study’s authors, led by Lihua E Budde, MD, PhD, of City of Hope in Duarte, California, published the findings in the Journal of Hematology & Oncology. The post Phase 1 data reported for anti-CD123 CAR T-cell therapy in relapsed or refractory AML, BPDCN appeared first on SOHO Insider . ## [Drs. George Lenz and Loretta Nastoupil discuss phase 3 FRONTMIND study](https://sohoinsider.com/lymphoma/drs-george-lenz-and-loretta-nastoupil-discuss-phase-3-frontmind-study/?utm_source=rss&utm_medium=rss&utm_campaign=drs-george-lenz-and-loretta-nastoupil-discuss-phase-3-frontmind-study) _2026-08-18 · Leah Sherwood · SOHO Insider_ From EHA 2026, Dr. Loretta Nastoupil interviews Dr. Georg Lenz on the phase 3 FRONTMIND study, a randomised, double-blind, placebo-controlled study that evaluated tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma. The post Drs. George Lenz and Loretta Nastoupil discuss phase 3 FRONTMIND study appeared first on… ## [FDA grants accelerated approval to iberdomide combo in multiple myeloma](https://sohoinsider.com/news/fda-grants-accelerated-approval-to-iberdomide-combo-in-multiple-myeloma/?utm_source=rss&utm_medium=rss&utm_campaign=fda-grants-accelerated-approval-to-iberdomide-combo-in-multiple-myeloma) _2026-08-14 · SOHO Insider Editors · SOHO Insider_ ...the approval is based on results from the Phase 3 EXCALIBER-RRMM trial, which showed iberdomide significantly improved minimal residual disease (MRD)-negative complete response (CR) rates. The post FDA grants accelerated approval to iberdomide combo in multiple myeloma appeared first on SOHO Insider . ## [Capricor soars on potential FDA review extension, filing amendments](https://www.biospace.com/drug-development/capricor-soars-on-potential-fda-review-extension-filing-amendments) _2026-08-14 · Gabrielle Masson · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Capricor Therapeutics’ CEO Linda Marbán believes the FDA is willing to work with the biotech as the Aug. 22 deadline approaches for its Duchenne muscular dystrophy cell therapy deramiocel, with the biotech’s stock climbing 68% on the update. ## [BMS welcomes new multiple myeloma drug as generics batter current portfolio](https://www.biospace.com/fda/bms-welcomes-new-multiple-myeloma-drug-as-generics-batter-current-portfolio) _2026-08-14 · Tristan Manalac · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ The FDA approves Zenbexus just as copycat competitors depress sales of Bristol Myers Squibb’s multiple myeloma drugs Pomalyst and Revlimid, which crashed 71% and 49% year-on-year, respectively, in the second quarter. ## [Nascent US psychedelic therapy opportunity attracts overseas manufacturers](https://www.biospace.com/drug-development/nascent-us-psychedelic-therapy-opportunity-attracts-overseas-manufacturers) _2026-08-14 · Nick Paul Taylor · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Companies that manufacture MDMA and psilocybin for patients in other countries are looking to use their experience to access the potential U.S. market. ## [Post-transplantation outcomes have improved for Hodgkin lymphoma](https://sohoinsider.com/lymphoma/post-transplantation-outcomes-have-improved-for-hodgkin-lymphoma/?utm_source=rss&utm_medium=rss&utm_campaign=post-transplantation-outcomes-have-improved-for-hodgkin-lymphoma) _2026-08-14 · Leah Sherwood · SOHO Insider_ The improved post-transplantation outcomes are likely due to the introduction of novel therapeutic agents, alongside advances in donor selection, conditioning regimens, and graft-versus-host disease prophylaxis, the authors suggested. The post Post-transplantation outcomes have improved for Hodgkin lymphoma appeared first on SOHO Insider . ## [Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition](https://www.biospace.com/drug-development/taiho-and-cullinans-zipalertinib-clears-phase-3-teeing-up-first-line-competition) _2026-08-13 · Gabrielle Masson · FDA News: Approvals, Adcomms, Complete Response Letters and Guidances_ Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February. ## [Fedratinib demonstrates favorable OS in MDS/MPN overlap syndrome](https://sohoinsider.com/myeloproliferative-neoplasms/fedratinib-demonstrates-favorable-os-in-mds-mpn-overlap-syndrome/?utm_source=rss&utm_medium=rss&utm_campaign=fedratinib-demonstrates-favorable-os-in-mds-mpn-overlap-syndrome) _2026-08-11 · SOHO Insider Editors · SOHO Insider_ The results showed a 30% spleen response rate and a 47% symptom response rate among evaluable patients. Overall survival reached around 37 months, which compares favorably to historical controls where survival is typically between one and three years. The post Fedratinib demonstrates favorable OS in MDS/MPN overlap syndrome appeared first on SOHO Insider . ## [NICE recommends acalabrutinib for mantle cell lymphoma, chronic lymphocytic leukemia](https://sohoinsider.com/news/nice-recommends-acalabrutinib-for-mantle-cell-lymphoma-chronic-lymphocytic-leukemia/?utm_source=rss&utm_medium=rss&utm_campaign=nice-recommends-acalabrutinib-for-mantle-cell-lymphoma-chronic-lymphocytic-leukemia) _2026-08-11 · SOHO Insider Editors · SOHO Insider_ The draft guidance expands frontline options for patients who are ineligible for stem cell transplants or who require oral therapies. The post NICE recommends acalabrutinib for mantle cell lymphoma, chronic lymphocytic leukemia appeared first on SOHO Insider . ## [Ship software peacefully (Sponsored)](https://crawlproof.com/a/7HvoqvprRv1l) _2026-08-11 · **Sponsored**_ Connect your repo and deploy instantly — Railway handles config, scaling, and monitoring. ## [FDA approves subcutaneous isatuximab-irfc for multiple myeloma](https://sohoinsider.com/news/fda-approves-subcutaneous-isatuximab-irfc-for-multiple-myeloma/?utm_source=rss&utm_medium=rss&utm_campaign=fda-approves-subcutaneous-isatuximab-irfc-for-multiple-myeloma) _2026-08-11 · SOHO Insider Editors · SOHO Insider_ Isatuximab-irfc is currently approved across three indications in the US, including in combination with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant, Sanofi reported in the release. The post FDA approves subcutaneous isatuximab-irfc for multiple myeloma appeared first on SOHO Insider . ## [ASCO and EHA 2026 updates on the third-gen TKI olverembatinib](https://sohoinsider.com/leukemia/asco-and-eha-2026-updates-on-the-third-gen-tki-olverembatinib/?utm_source=rss&utm_medium=rss&utm_campaign=asco-and-eha-2026-updates-on-the-third-gen-tki-olverembatinib) _2026-08-11 · SOHO Insider Editors · SOHO Insider_ Dr. Jabbour details safety and efficacy findings for an olverembatinib plus blinatumomab combination in leukemia. The post ASCO and EHA 2026 updates on the third-gen TKI olverembatinib appeared first on SOHO Insider . ## [Global KMT2A MRD testing launched for AML,ALL](https://sohoinsider.com/news/global-kmt2a-mrd-testing-launched-for-aml-all/?utm_source=rss&utm_medium=rss&utm_campaign=global-kmt2a-mrd-testing-launched-for-aml-all) _2026-08-10 · SOHO Insider Editors · SOHO Insider_ The standardized assay targets common KMT2A partner fusion genes to support disease characterization and longitudinal monitoring in menin inhibitor clinical trials. The post Global KMT2A MRD testing launched for AML,ALL appeared first on SOHO Insider .