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News and Press Releases

Johnson & Johnson receives CHMP positive opinion for AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations

AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

Tempus Reveals Its AI-Driven IPS Test More Accurately Predicts Immunotherapy Benefit Compared to Conventional Biomarkers

27 January 2026 -- Illinois, US -- Tempus AI, Inc, a technology company leading the adoption of AI to advance precision medicine, today announced results from a new study demonstrating that...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 27, 2026

Tempus
support@tempus.com
600 W Chicago Ave. Ste 510, Chicago, IL 60654

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

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

Natera Announces Next Breakthrough in MRD-Based Risk Stratification, Leveraging Multi-Modal AI Modeling

New AI-derived model integrates longitudinal ctDNA and clinical data with digital pathology and tumor sequencing data, to refine recurrence risk assessment and outcomes prediction 13 January 2026 -- Texas, US...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 13, 2026

Natera
13011 McCallen Pass Building A Suite 100 Austin, TX 78753

Personalis Pioneers Advancement in MRD Testing with the Launch of its Real-Time Variant Tracker

New NeXT Personal extension empowers clinicians to identify emerging resistance and therapeutically targetable mutations during disease monitoring and surveillance 12 January 2026 -- California, US -- Personalis, Inc, a leader...

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

Personalis
info@personalis.com
6600 Dumbarton Circle Fremont, CA 94555 USA

ConcertAI and Foundation Medicine Integrate Genomic and Clinical Data to Transform Translational Research and Efficient Drug Development

ConcertAI now offers industry’s most comprehensive clinically-linked dataset to life science organizations Dataset encompasses ConcertAI’s full network of industry partners, representing nearly half a million patients Applications span entire drug...

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

Foundation Medicine
Biopharma.leads@foundationmedicine.com
400 Summer Street, Boston, MA 02210

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

Allogene Therapeutics Positions 2026 as a Program-Defining Year for Scalable, Real-World Allogeneic CAR T

1H 2026 Catalyst Stack Anticipated to Validate Scalable, Off-the-Shelf CAR T in Oncology and Autoimmune Disease Interim Futility Analysis of MRD Clearance from the Pivotal Phase 2 ALPHA3 Trial with...

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

Allogene Therapeutics
210 E. Grand Avenue South San Francisco, CA 94080

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

T-CURX Announces $20M Series A First Closing Led by BiomedVC to Fund Pipeline of Clinical-Stage CAR-T Programs and Advance Proprietary Non-Viral In Vivo CAR-T Platform

17 December 2025 -- Würzburg, Germany -- T-CURX GmbH (T-CURX) today announces the first closing of a $20M (€ 17.7M) Series A financing with a syndicate of European and Asian investors...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 17, 2025

T-CURX
info@t-curx.com
Innovations- und Gründerzentrum Würzburg Friedrich-Bergius-Ring 15 97076 Würzburg Deutschland/Germany

Leucid Bio and Syenex Announce Strategic Collaboration for In Vivo CAR-T Cell Engineering

Enables in vivo delivery of LEU011 harnessing the VivoCell Platform 15 December 2025 -- London, UK and Illinois, US -- Leucid Bio, a privately-held biotechnology company developing innovative Chimeric Antigen Receptor...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 15, 2025

Leucid Bio
info@leucid.com
3rd Floor, Bermondsey Wing Guy's Hospital London SE1 9RT