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News and Press Releases

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

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

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

SOM Biotech
Baldiri Reixac, 4 (08028) Barcelona, Spain

Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years

If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 1, 2025

Pharming Group NV
info@pharming.com
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands

Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration

Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can...

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

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

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

Quidditas raises €2.62M to accelerate development of pioneering genome editing technology

Funding will enable company to expand research capacity and scale up unique genome editing technology designed to treat complex, rare diseases while also opening new avenues for protein bioproduction and...

Category: BioManufacturing, Drug Discovery, Other, Pharmaceutical
Posted: May 12, 2025

Quidditas Therapeutics
contact@quidditastherapeutics.com
23, rue des bourguignons 91310 MONTLHERY

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

CN Bio and Pharmaron establish long-term strategic partnership to develop OOC technologies on a global R&D platform

Partnership to validate and promote the application of CN Bio’s PhysioMimix technology, with future opportunities for novel application and assay development 24 April 2025 -- Cambridge, UK -- CN Bio,...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: April 24, 2025

CN-Bio
enquiries@cn-bio.com
30 Upper High Street, Thame, Oxfordshire, OX9 3EZ

Boehringer Ingelheim and Tessellate Bio partner to develop first-in-class precision treatments for people with hard-to-treat cancers

23 April 2025 -- Ingelheim, Germany and Amsterdam, the Netherlands -- Boehringer Ingelheim and Tessellate Bio, a precision oncology company with a focus on developing novel synthetic lethality approaches, have...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: April 23, 2025

Boehringer Ingelheim
Binger Strasse 173 55216 Ingelheim am Rhein

Pistoia Alliance Launches Initiative to Assess Sustainability of Digital vs. Traditional Clinical Trial Approaches

New initiative will collect pharma and CRO data to refine industry carbon measurement of technologies like remote monitoring and eConsent, informing more sustainable trial design 20 March 2025, Massachusetts, US...

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

The Pistoia Alliance
info@pistoiaalliance.org
401 Edgewater Pl, Wakefield, Massachusetts, US

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