News and Press Releases
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
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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
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
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
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
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
CONNECTA Therapeutics to Advance CTH120 into Phase II Pediatric Development for Fragile X Syndrome with EIC Accelerator Support
CTH120 is a first-in-class neuroplasticity modulator with strong Phase I safety and tolerability data Awarded a €2.5M European Innovation Council (EIC) Accelerator grant to prepare for Phase II development in...
Category: Biotechnology, Clinical Trials, Drug Discovery
Posted: October 10, 2025
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European Marketing Application for AVT23, a Proposed Biosimilar to Xolair (omalizumab), Accepted by the European Medicines Agency
6 October 2025 -- London, UK and Reykjavik, Iceland -- Advanz Pharma Holdco Limited, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: October 6, 2025
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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
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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
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
Novo Nordisk A/S: Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar,...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 23, 2025
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
Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults
In laboratory studies, zoliflodacin has been shown to be active against Neisseria gonorrhoeae including multidrug-resistant strains If approved, zoliflodacin could become the first new antibiotic treatment for gonorrhea in decades. 10 June...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 10, 2025
Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of...
Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 2025
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