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News and Press Releases

MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis

5 January 2026 -- California and Massachusetts, US -- MapLight Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 5, 2026

MapLight Therapeutics
info@maplightrx.com
800 Chesapeake Drive, Redwood City, California 9406

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

AGC Biologics Partners with ATUM to Accelerate Timelines for Cell Line Development

New offering provides drug developers with flexible and powerful cell line development options for monoclonal antibodies, multi-specific and complex molecules   2 December 2025 -- Washington State, US -- As drug developers face increasing pressure to lower...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: December 2, 2025

AGC Biologics
contactus@agcbio.com

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

Infant Bacterial Therapeutics AB secures partnership with Recipharm Advanced Bio for commercial production of drug substance

IBP-9414 targets mortality and gastrointestinal injury in premature infants With Breakthrough Therapy designation for gastro-intestinal mortality and Rare Paediatric Disease designations, IBP-9414 is on an accelerated path to commercialisation   PPQ...

Category: BioManufacturing, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: December 1, 2025

Recipharm

Telomir and Mira Pharmaceuticals advance through key development milestones with Recipharm support

Telomir-1 has now entered GMP preparation, and Ketamir-2 has completed the Phase 1 SAD stage, reflecting steady advancement of both programmes These milestones mark tangible progress in development and demonstrate...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 26, 2025

Recipharm

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

CARBOGEN AMCIS Announces Successful Refinancing and Enhancement of their Syndicated Credit Facilities to Support Continued Growth and Investment

12 November 2025 -- Bubendorf, Switzerland -- CARBOGEN AMCIS, a subsidiary of Dishman Carbogen Amcis, and a global top-tier Contract Development and Manufacturing Organisation (CDMO), today announced the successful refinancing and...

Category: BioManufacturing, Manufacturing and Packing, Other, Pharmaceutical
Posted: November 12, 2025

CARBOGEN AMCIS
info@carbogen-amcis.com
Hauptstrasse 171 CH-4416 Bubendorf Switzerland

Naobios and Tokyo Metropolitan Institute of Medical Science partner to develop new live-attenuated vaccine against mpox

 Partnership aims to commercialize new mpox vaccine - with higher level of safety - by 2027 23 October 2025 -- Nantes, France, and Tokyo, Japan -- Naobios, a CDMO (Contract Development...

Category: BioManufacturing, Drug Delivery, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 23, 2025

Naobios
Operating office 6 rue Alain Bombard 44800 Saint-Herblain

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

Recipharm supports landmark trial of next generation pneumococcal vaccine developed by ImmBio and iiCON

Recipharm delivers cGMP manufacture of PnuBioVax® enabling progression to phase 2 clinical trials in Malawi Demonstrates Recipharm’s agility and flexibility, completing full tech transfer, scale-up and process optimisation within three...

Category: BioManufacturing, Drug Delivery, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 15, 2025

IAVI, Minapharm, and ProBioGen Announce Memorandum of Understanding to Progress Clinical Development, Manufacturing, Commercialization, and Access to Vaccines and Antibodies in Africa

Partners will advance end-to-end development of biologics for regionally prioritized diseases starting with Mpox and HIV 10 October 2025 -- Cairo, Egypt; Berlin, Germany; and New York, New York -- IAVI,...

Category: Biotechnology, Drug Delivery, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 10, 2025

ProBioGen
info@probiogen.de
Herbert-Bayer-Straße 8 13086 Berlin

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