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News and Press Releases

Iksuda Therapeutics receives FDA IND clearance for IKS014

FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical activity across...

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

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers

Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel, currently in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 16, 2025

SolasCure
wellington house East Rd, Petersfield, Cambridge CB1 1BH

Tiziana Life Sciences Announces Significant Reduction in Microglia Activation in PET Scan of Moderate Alzheimer’s Patient Treated with Intranasal Foralumab

9 May 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3...

Category: Biotechnology, Other, Pharmaceutical
Posted: May 9, 2025

Tiziana Life Sciences
info@tizianalifesciences.com
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom

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

OKYO Pharma
info@okyopharma.com
OKYO Pharma Floor 4, 14/15 Conduit St London W1S 2XJ

Leqembi ▼ (lecanemab) proposed Marketing Authorisation Variation for monthly intravenous maintenance dosing for the treatment of early Alzheimer’s disease in the UK is validated for evaluation by the MHRA

Proposed intravenous maintenance dosing application to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult UK patients after initial 18 months of treatment The...

Category: Other, Pharmaceutical
Posted: April 30, 2025

Eisai
4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan

Leqembi® (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorised in the European Union           

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 16, 2025

Eisai
4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan

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

PLL Therapeutics
contact@pll-therapeutics.com
10 Avenue Roger Lapébie 33140 Villenave d’Ornon France

Groundbreaking health research gets £7.6m boost as Academy of Medical Sciences funds emerging scientific leaders 

7 April 2025 -- London, UK -- In its largest-ever funding initiative for early-career researchers, the Academy of Medical Sciences is investing £7.6 million to tackle urgent health challenges from...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 7, 2025

The Academy of Medical Sciences
info@acmedsci.ac.uk
41 Portland Pl, London W1B 1QH

HEALEY ALS Platform Trial Preparation Shows Positive Respiratory Outcome of NUZ-001

Updates to HEALEY ALS Platform Trial Master Protocol have been made to enhance the potential of establishing a clinically meaningful outcome for patients, including: Treatment period extended from 24 to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 24, 2025

Neurizon Therapeutics
enquiries@neurizon.com
Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia

Fondazione Telethon Submits US Biological License Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Sydrome

11 March 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Biologics License Application (BLA) for the...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 11, 2025

Fondazione Telethon
info@telethon.it
Via Poerio 14 - 20129 Milano

OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain

10 March 2025 -- London, UK and New York, US -- OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 10, 2025

OKYO Pharma
info@okyopharma.com
OKYO Pharma Floor 4, 14/15 Conduit St London W1S 2XJ

Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe

FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...

Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025

Bioxodes
info@bioxodes.com
Parc d'activités Aéropole Rue Santos-Dumont, 1 6041 Gosselies, Belgique

Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial

4 March 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 4, 2025

Tiziana Life Sciences
info@tizianalifesciences.com
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom

Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis

Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025

Boehringer Ingelheim
Binger Strasse 173 55216 Ingelheim am Rhein

Opella reaches study milestone for Cialis

21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...

Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK