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News and Press Releases

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

Eisai presents 4-year Leqembi (lecanemab) open-label extension data from post-hoc sub-group analysis at German neurology congress

Clarity AD open-label extension data show that after four years of continuous lecanemab treatment in apolipoprotein E ε4 (ApoE ε4*) non-carriers and heterozygotes, patients continued to accrue benefit relative to...

Category: Clinical Trials, Other, Pharmaceutical
Posted: November 12, 2025

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

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

Leqembi (lecanemab) long-term 36-month open-label extension data from post-hoc sub-group analysis of ApoE ε4 non-carriers and heterozygotes presented at Alzheimer’s disease congress in Switzerland

Clarity AD open-label extension data show three years of continuous lecanemab treatment in apolipoprotein E ε4 (ApoE ε4) non-carrier and heterozygote patients continued to accrue benefit relative to the Alzheimer's...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 29, 2025

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

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

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