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News and Press Releases

CARBOGEN AMCIS Shanghai Site achieves successful outcome in Unannounced NMPA GMP Inspection

China’s NMPA confirms robust GMP compliance at CARBOGEN AMCIS Shanghai, with no observations identified following a comprehensive unannounced inspection 6 May 2026 -- Bubendorf, Switzerland -- CARBOGEN AMCIS, a Switzerland-based...

Category: BioManufacturing, Clinical Trials, Other, Pharmaceutical
Posted: May 6, 2026

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

U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder

29 April 2026 -- California, US -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 29, 2026

Laguna Diagnostics
info@lagunadiagnostics.com

U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 20, 2026

Astellas
2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan

Ofichem unifies brands under single CDMO and pharmaceutical supplier

One Ofichem. One voice. A more connected approach to pharmaceutical partnerships 8 April 2026 -- Ter Apel, the Netherlands -- Ofichem has brought its brands - Ofichem BV, Ofipharma, Ofimedicine,...

Category: Drug Delivery, Logistics, Manufacturing and Packing, Other
Posted: April 8, 2026

Ofichem
info@ofichem.com
Laboratorium Ofichem BV, Heembadweg 5, 9561 CZ Ter Apel The Netherlands

Samsung Biologics completes acquisition of GSK’s manufacturing facility in Rockville, Maryland

Adds 60,000 liters of drug substance capacity, bringing the total to 845,000 liters Marks Samsung Biologics’ geographical diversification and establishes its first U.S. manufacturing presence, expanding regional client support Plans...

Category: BioManufacturing, Manufacturing and Packing, Other, Pharmaceutical
Posted: March 31, 2026

Samsung Biologics
300, Songdo bio-daero, Yeonsu-gu, Incheon, Republic of Korea

Lonza Launches Media Development Lab in Singapore for Cell Culture Media Optimisation

New media development services designed to optimize cell culture media development and identify robust, scalable media formulations driving cell culture performance and reliability The offering is designed to improve performance,...

Category: BioManufacturing, Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: March 26, 2026

Lonza
Muenchensteinerstrasse 38 Basel, 4002

Samsung Biologics Recognized for Advancing Sustainability at 2026 CDMO Leadership Awards

• Reinforcing long-term commitment to embedding sustainability across operations and partnerships• Continuing to support clients in delivering high-quality, life-saving medicines to patients worldwide. 16 March 2026 -- Incheon, South Korea...

Category: BioManufacturing, Other, Pharmaceutical
Posted: March 16, 2026

Samsung Biologics
300, Songdo bio-daero, Yeonsu-gu, Incheon, Republic of Korea

Avid Bioservices Announces Grand Opening of New Early Phase Center of Excellence in Costa Mesa, California

24 February 2026 -- California, US -- Avid Bioservices, Inc., a dedicated biologics CDMO, today announced the grand opening of its new Early Phase Center of Excellence, a state of...

Category: BioManufacturing, Manufacturing and Packing, Other, Pharmaceutical
Posted: February 24, 2026

Avid Bioservices
14191 Myford Road Tustin, California 92780

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