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

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ALK receives positive CHMP opinion for EURneffy 1mg (nasal adrenaline spray) for emergency anaphylaxis treatment in children (≥15kg)

30 January 2026 -- Hørsholm – Denmark -- Today ALK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...

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

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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

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Dawnzera (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema

Donidalorsen is a first-in-class RNA-targeted prophylactic therapy for patients with hereditary angioedema (HAE) Donidalorsen demonstrated a significant reduction in HAE attack rate compared with placebo in the Phase 3 OASIS-HAE...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 2026

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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

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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

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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

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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

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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

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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

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

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Astellas To Present New Data on XOSPATA (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting

Presentations include pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE data on post-transplant gilteritinib resumption in relapsed or refractory FLT3m+ AML Findings from the Phase 3 MORPHO trial...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 5, 2025

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Jemperli®▼(dostarlimab) with platinum-based chemotherapy to be made available on the NHS for all eligible patients in England for first-line treatment of primary advanced or recurrent endometrial cancer

Jemperli (dostarlimab) with platinum-based chemotherapy to be made available on the NHS for all eligible patients in England for first-line treatment of primary advanced or recurrent endometrial cancer Following a...

Category: Drug Delivery, Other, Pharmaceutical
Posted: November 25, 2025

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Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria

Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies showing Dupixent significantly...

Category: Drug Discovery, Other, Pharmaceutical
Posted: November 25, 2025

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Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

Novel approach harnessing the power of the complement system to drive potent cell depletion Single-dose study shows rapid and sustained immune cell depletion in blood and tissues with a very...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 11, 2025

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