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News and Press Releases

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

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

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

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

Lundbeck
Iveco House Station Road Watford Hertfordshire WD17 1ET

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

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

Lundbeck
Iveco House Station Road Watford Hertfordshire WD17 1ET

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

PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)

Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...

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

PureTech Health
info@puretechhealth.com
PureTech Health 6 Tide Street Boston, MA 02210

QurAlis Invited to Present at 43rd Annual J.P. Morgan Healthcare Conference

7 January 2025 -- Massaschusetts, US --  QurAlis Corporation, a clinical-stage biotechnology company driving scientific breakthroughs into powerful precision medicines that have the potential to alter the trajectory of amyotrophic...

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

QurAlis
info@quralis.com
100 Cambridgepark Dr, Cambridge, MA 02140

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

Neumora
investors@neumoratx.com
490 Arsenal Way, Suite 200 Watertown, MA 02472

Medidata and Cogstate Strike Strategic Partnership Transforming Clinical Trials in Neurology with Clinical Outcome Assessment (eCOA) and Clinician Solutions Powered by AI and Advanced Analytics

Science-driven collaboration ameliorates neurological assessments and endpoint data quality, enhances the rater and patient experience, and integrates Medidata App innovations with Cogstate capabilities 29 October 2024 -- New York, US...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other
Posted: October 29, 2024

Medidata
helpdesk@mdsol.com
350 Hudson Street New York, NY 10014 USA