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News and Press Releases

Recipharm expands manufacturing to meet demanding FDA requirements

Established a new, dedicated non-bacterial beta-lactam manufacturing facility in response to FDA guidance Secured a strategic partnership with an innovative biopharma company seeking rapid regulatory compliance Developed a scalable platform...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 26, 2026

Recipharm

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

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports: a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Relmada Therapeutics
info@relmada.com
2222 Ponce de Leon Blvd. Floor 3 Coral Gables, FL 33134

VectorY Therapeutics Receives FDA Fast Track Designation for VTx-002, a Firstin-Class Vectorized Antibody Targeting Underlying Disease Biology in ALS

Designation enables an enhanced development path for VTx-002 and underscores its disease-modifying potential in ALS, a universally fatal disease with no cure Milestone follows recent IND clearance and supports continued...

Category: BioManufacturing, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

VectorY Therapeutics
info@vectorytx.com
Science Park Matrix Innovation Center 408 1098 XH Amsterdam

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

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