News and Press Releases

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design Phase 3 initiation targeted...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 5, 2026

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MindMaze Therapeutics: Consolidating a Global Approach to Reimbursement for Next-Generation Therapeutics

23 December 2025 -- Geneva, Switzerland -- MindMaze Therapeutics Holding SA, a commercial-stage company delivering evidence-based, precision digital treatments for neurological diseases, today outlined the evolution of its global reimbursement...

Category: Logistics, Other, Pharmaceutical
Posted: December 23, 2025

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Vandria Reports Positive Phase 1 Target Engagement Data for VNA-318, Supporting Further Development in Alzheimer’s Disease

Results presented at the 18th Clinical Trials in Alzheimer's Disease (CTAD) meeting, San Diego, December 1-4 VNA-318, an oral brain-penetrant small molecule therapeutic modulates a novel target to reduce inflammation...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 2, 2025

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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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ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

US FDA clearance now allows use of the ARC-EX System both in clinics and homes ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation...

Category: Biotechnology, Other, Pharmaceutical
Posted: November 17, 2025

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Lundbeck and Contera Pharma announce research collaboration to advance RNA-targeting medicines for serious neurological conditions

20 October 2025 -- Valby, Denmark -- H. Lundbeck A/S and Contera Pharma today announced a strategic research collaboration aiming to accelerate the discovery and development of innovative oligonucleotide-based medicines...

Category: Biotechnology, Drug Discovery, Logistics, Other, Pharmaceutical
Posted: October 20, 2025

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ONWARD Medical Provides Preliminary Q3 2025 Update Highlighting Accelerating ARC-EX Adoption in the United States

13 October 2025 -- EINDHOVEN, the Netherlands -- ONWARD Medical N.V., the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI)...

Category: Drug Discovery, Other, Pharmaceutical
Posted: October 13, 2025

Schimmelt 2. 5656 AE, Eindhoven, the Netherlands

Nilo Therapeutics launches with $101 million Series A financing to advance a new class of medicines targeting neural circuits in immune disease and appoints Kim Seth as Chief Executive Officer

Series A led by The Column Group, DCVC Bio, and Lux Capital, with participation from the Gates Foundation and Alexandria Venture Investments 8 October 2025 -- New York, New York...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 8, 2025

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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Lundbeck to present positive pipeline data at American Academy of Neurology (AAN) Annual Meeting

4 April 2025 -- Valby, Denmark -- H. Lundbeck A/S (Lundbeck) to present positive interim results from the PACIFIC trial open-label extension investigating bexicaserin, in addition to new analyses from...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 4, 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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Lundbeck announces positive results from 12-month Open-Label Extension (OLE) of the PACIFIC trial evaluating bexicaserin in participants with Developmental and Epileptic Encephalopathies

Bexicaserin achieved an overall median seizure reduction of 59.3 percent in countable motor seizures over a 12-month open-label extension (OLE) treatment period. The treatment with bexicaserin demonstrated favorable safety and...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2025

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Neumora Therapeutics Reports Data from KOASTAL-1 Study of Navacaprant in Major Depressive Disorder

Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo Navacaprant showed an efficacy signal in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 2, 2025

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