News and Press Releases

Jemperli®▼(dostarlimab) with platinum-based chemotherapy to be made available on the NHS for all eligible patients in England for first-line treatment of primary advanced or recurrent endometrial cancer

Jemperli (dostarlimab) with platinum-based chemotherapy to be made available on the NHS for all eligible patients in England for first-line treatment of primary advanced or recurrent endometrial cancer Following a...

Category: Drug Delivery, Other, Pharmaceutical
Posted: November 25, 2025

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Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 23, 2025

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NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS

21 May 2025 -- Surrey, UK -- Pfizer Ltd announced today that the National Institute for Health and Care Excellence (NICE) has published final draft guidance which recommends Hympavzi (marstacimab)...

Category: Drug Discovery, Other, Pharmaceutical
Posted: May 21, 2025

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NICE recommends Yselty▼ (linzagolix) for symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis

1 May 2025 -- London, UK -- Theramex is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended NHS reimbursement of the extended indication...

Category: Other, Pharmaceutical
Posted: May 1, 2025

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Pharming receives positive recommendation from NICE for Joenja▼(leniolisib) as a treatment for APDS

Joenja® is the first and only medicine specifically for APDS to be reimbursed within the NHS Recommended for adult and pediatric patients 12 years of age and older with activated...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 23, 2025

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NICE publishes guidance in England & Wales recommending Altuvoct (efanesoctocog alfa) as a treatment option for people with severe haemophilia A aged 2 years and over

2 April 2025 -- Stockholm, Sweden -- Sobi in the UK today announced that the National Institute for Health and Care Excellence (NICE) has issued its Final Guidance in England...

Category: Clinical Trials, Other, Pharmaceutical
Posted: April 2, 2025

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New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma

Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV IRAKLIA is...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025

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ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients

New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd alone New detailed results from the GMMG-HD7...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 9, 2024

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DARZALEX® (daratumumab) subcutaneous formulation shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smouldering multiple myeloma

First subcutaneous anti-CD38 therapy to demonstrate potential to prevent end-organ damage, and extendprogression-free survival and overall survival based on findings from Phase 3 AQUILA study 8 December 2024 – BEERSE,...

Category: Clinical Trials
Posted: December 9, 2024

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CARVYKTI® ▼ (ciltacabtagene autoleucel; cilta-cel) is the first cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line

45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after threeyear follow-up in landmark CARTITUDE-4 study Data featured in a late-breaking oral presentation at the 2024...

Category:
Posted: October 1, 2024

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DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma

Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024

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TALVEY (talquetamab) demonstrated highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma

24-month overall survival rate of 67% achieved with talquetamab 0.8mg/kg biweekly dosing in the phase 1/2 MonumenTAL-1 study 14 June 2024 – Beerse, Belgium – Janssen-Cilag International NV, a Johnson...

Category: Biotechnology, Drug Discovery
Posted: June 17, 2024

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CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma

73% reduction in risk of disease progression or death seen with cilta-cel in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy...

Category: Biotechnology, Clinical Trials, Drug Discovery
Posted: June 4, 2024

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TECVAYLI▼ (teclistamab) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma

New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing Separate analyses from the MajesTEC-1 and OPTec...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 3, 2024

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DARZALEX (daratumumab)-based regimens significantly improved clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma

88% of transplant-eligible patients achieved a complete response or better, and 47% of patients sustained MRD-negativity for longer than one year with daratumumab subcutaneous formulation-based regimens in the phase 3...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 3, 2024

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