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News and Press Releases

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

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

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

Santhera Announces Approval in Canada for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy

Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD...

Category: Other, Pharmaceutical
Posted: October 3, 2025

Santhera
office@santhera.com
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland

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

Lonza’s Synaffix Collaborates with Qurient Therapeutics to Enable Development of Dual-Payload ADC

License agreement centered around technology enabling dual-payload ADC Unique combination of Synaffix’s exatecan-based technology with Qurient’s CDK7 inhibitor. 25 September 2025 -- Amsterdam, The Netherlands and Seongnam-Si, Korea -- Synaffix B.V.,...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: September 25, 2025

Synaffix
admin.synaffix@lonza.com
Pivot Park, Curie Building Kloosterstraat 9 5349 AB Oss 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

NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS

21 May 2025 -- Surrey, UK -- Pfizer Ltd announced today that the National Institute for Health and Care Excellence (NICE) has published final draft guidance which recommends Hympavzi (marstacimab)...

Category: Drug Discovery, Other, Pharmaceutical
Posted: May 21, 2025

Pfizer
235 East 42nd Street NY, NY 10017