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News and Press Releases

Leucid Bio and Syenex Announce Strategic Collaboration for In Vivo CAR-T Cell Engineering

Enables in vivo delivery of LEU011 harnessing the VivoCell Platform 15 December 2025 -- London, UK and Illinois, US -- Leucid Bio, a privately-held biotechnology company developing innovative Chimeric Antigen Receptor...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 15, 2025

Leucid Bio
info@leucid.com
3rd Floor, Bermondsey Wing Guy's Hospital London SE1 9RT

FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial

FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol This marks the official entry of NUZ-001 as Regimen I in the...

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

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

Xlife Sciences AG Delivers Breakthrough in Early Alzheimer’s Detection, Unlocking Major Market Opportunity

1 December 2025 -- Zurich, Switzerland -- Xlife Sciences AG, together with saniva diagnostics GmbH, today announced a landmark achievement: NeuroMex is the world’s first certified and clinically validated medical device for...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: December 1, 2025

Xlife Sciences
info@xlifesciences.ch
Talacker 35 8001 Zürich Switzerland

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

GSK
980 Great West Rd, London TW8 9GS

Annovis Announces FDA Meeting to Discuss Parkinson’s Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer’s Disease Study

18 November 2025 -- Pennsylvania, US -- Annovis Bio, Inc, a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 18, 2025

Annovis
info@annovisbio.com
101 Lindenwood Drive, Suite 225 Malvern, PA 19355

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

ONWARD Medical
investors@onwd.com
Schimmelt 2. 5656 AE, Eindhoven, the Netherlands

Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

Novel approach harnessing the power of the complement system to drive potent cell depletion Single-dose study shows rapid and sustained immune cell depletion in blood and tissues with a very...

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

Commit Biologics
info@commitbio.com
Universitetsbyen 83 8000 Aarhus C, Denmark

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

Evidence of clinical activity observed in Cohort 8, including stringent complete remission in two patients from Cohort 8 HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 6, 2025

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

Ryvu Therapeutics Announces Three Abstracts on Romaciclib (RVU120) and One Abstract on Dapolsertib (MEN1703) at the 2025 ASH Annual Meeting

Romaciclib continues to show efficacy in AML: Data from the Phase II RIVER-81 trial suggest that romaciclib restores sensitivity to venetoclax in resistant AML, inducing complete remissions with a favorable safety profile Clinical activity in myelofibrosis (MF): Interim results from the Phase II POTAMI-61 study indicate clinically meaningful spleen volume...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 3, 2025

Ryvu Therapeutics
ryvu@ryvu.com
R&D Center for Innovative Drugs Leona Henryka Sternbacha 2 30-394 Kraków, Poland

Ryvu Therapeutics Presents RVU305 (PRMT5i) and ONCO Prime Platform Data at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

RVU305, a potentially best-in-class, brain-permeable MTA-cooperative PRMT5 inhibitor, demonstrates strong and selective antitumor efficacy in MTAP-deleted glioblastoma models, with confirmed brain exposure and a favorable safety profile supporting IND/CTA-enabling studies...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 27, 2025

Ryvu Therapeutics
ryvu@ryvu.com
R&D Center for Innovative Drugs Leona Henryka Sternbacha 2 30-394 Kraków, Poland

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

Iksuda presents encouraging IKS014 Phase 1 data at ESMO

New safety, efficacy and pharmacokinetic results presented from dose escalation portion of the study Anti-tumour activity observed across all dose levels and in various tumour indications 20 October 2025 --...

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

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

Iksuda to present IKS014 Phase 1 data at ESMO

14 October 2025 -- Newcastle, UK -- Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs), will present new data from its Phase 1 study of IKS014, a...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 14, 2025

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

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