News and Press Releases

MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis

5 January 2026 -- California and Massachusetts, US -- MapLight Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an...

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

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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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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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New collaborative strategy platform launches to empower biopharma teams to reach peak sales faster and with greater confidence

11 November 2025 -- London, UK -- In a drug development landscape defined by shifting policies, geopolitical uncertainty, and increasing competitive pressure, a new collaborative strategy platform, Nmblr, has launched to empower...

Category: Biotechnology, Drug Discovery, Logistics, Other, Pharmaceutical
Posted: November 11, 2025

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

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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

BIO-Europe 2025

10 July 2025 -- Vienna, Austria -- BIO-Europe, Europe's premier biopharma partnering event, is heading to Vienna, Austria on November 3-5, 2025, followed by Digital Partnering on November 11-12. Drawing...

Category: BioManufacturing, Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: July 10, 2025

FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain

1 May 2025 -- London, UK and New York, US -- OKYO Pharma Limited, an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 1, 2025

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PLL Therapeutics enrolls first patient in phase I/II trial of drug candidate PLL001 for Amyotrophic Lateral Sclerosis (ALS)

Multi-stage Australian study will evaluate safety of PLL001 in 12 ALS patients, testing three different doses along with placebo 140 ALS patients will participate in second stage of study to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 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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OKYO Pharma Announces Positive Data in Long-Term Stability of Urcosimod

Urcosimod in Phase 2 clinical trial for Neuropathic Corneal Pain shown to have Long-Term Stability Urcosimod stable in single-use ampoules for more than 2½ years FDA requires drug to show...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 31, 2025

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Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline

Dren Bio deep B-cell depleter program has the potential to reset the immune system Acquisition underpins path for Sanofi becoming leading immunology company Sanofi to pay $600 million up front....

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 20, 2025

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