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News and Press Releases

Levicept Announces FDA Acceptance of IND Application for LEVI-04, a Potentially Disease-Modifying Treatment for Osteoarthritis

20 January 2026 -- Sandwich, UK -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the US Food and...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026

Levicept
info@levicept.com
Innovation House Discovery Park Ramsgate Road Sandwich Kent CT13 9ND

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026

Samsung Bioepis
76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United States Therapy granted United States Food and Drug Administration (FDA) Fast Track and Orphan Drug designations Pompe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

AskBio
info@askbio.com
20 T.W. Alexander Drive Suite, 110 Research Triangle Park, NC 27709

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design Phase 3 initiation targeted...

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

GH Research
info@ghres.com
Joshua Dawson House Dawson Street Dublin 2, D02 RY95 Ireland

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

Rezon Bio launches as a European biologics CDMO combining cost efficiency and digital innovation.

New brand with proven track record – EMA and FDA-audited mirrored-capability sites in Poland provide an accelerated path from development to commercialization 29 September 2025 -- Gdańsk, Poland -- Rezon...

Category: BioManufacturing, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: September 29, 2025

Rezon Bio
office@rezonbio.com
Trzy Lipy 3, Building A 80-172 Gdansk, Poland

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

Recursion Announces FDA Clearance of Investigational New Drug Application for REC-1245, a Potential First-In-Class RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma

First program to combine Recursion’s end-to-end suite of AI-enabled active learning modules, resulting in target identification to IND enabling studies in under 18 months Plan to initiate dosing of Phase...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 2, 2024

Recursion
info@recursion.com
41 S Rio Grande Street Salt Lake City, UT 84101

Asimov achieves 10x improvement in lentiviral production, launches new stable cell line development service

Stable lentiviral (LV) cell line development service achieves unconcentrated titres >1E9 TU/mL for therapeutic transgenes Fully stable cell lines have all viral genes and transgene stably integrated, enabling biomanufacturing scalability...

Category: Biotechnology, Pharmaceutical
Posted: April 29, 2024

Asimov
hello@asimov.com
Asimov, Inc. 201 Brookline Avenue Suite 1201 Boston, MA 02215

Abzena launches AbZelect platforms for improving cell line development efficiency on the pathway to IND

16 January 2023 -- California, US -- Abzena, the leading end-to-end CDMO for biologics and bioconjugates, has launched AbZelect and AbZelectPRO cell line development (CLD) platforms for accelerating the generation...

Category: Biotechnology
Posted: January 16, 2024

Abzena
Babraham Research Campus, Cambridge, CB22 3AT United Kingdom