News and Press Releases

EMA Approves Updated Safety Information for Kite’s YESCARTA and TECARTUS Allow for a More Flexible Post-Infusion Management Approach

Update Enhances Convenience and Flexibility for Healthcare Professionals and Eligible Patients, while Maintaining CAR-T Safety Management Standards 24 April 2026 -- Stockley Park, UK -- Gilead and Kite Oncology today announced...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 24, 2026

Johnson & Johnson’s DARZALEX (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers

Landmark decision by CHMP grants approval for self or caregiver administration for patients living with multiple myeloma Milestone is a testament to ten years of daratumumab experience and innovation, continuing...

Category: Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Pharmaceutical
Posted: March 27, 2026

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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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SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

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European Marketing Application for AVT23, a Proposed Biosimilar to Xolair (omalizumab), Accepted by the European Medicines Agency

6 October 2025 -- London, UK and Reykjavik, Iceland -- Advanz Pharma Holdco Limited, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: October 6, 2025

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Novo Nordisk A/S: Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities

Pending a decision from the European Commission, Ozempic (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar,...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 23, 2025

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Kite’s CAR T-Cell Therapy Data Show Real-World Patient Benefit and Durable Response Across Difficult-to-Treat Blood Cancers

Largest Real-World (RW) Analyses of Yescarta® (Axicabtagene Ciloleucel) Show 74% Overall Survival (OS) at 12 Months in Second-Line Relapsed/Refractory Large B-cell Lymphoma (LBCL), Consistent with OS Reported in Pivotal ZUMA-7 Study,...

Category: Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Other, Pharmaceutical
Posted: June 12, 2025

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Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer

Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of...

Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 2025

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ViroCell manufactured a GMP lentiviral vector for UCL to accelerate research into prevention of relapse in childhood blood cancer

UCL leveraged ViroCell’s expertise in lentiviral vector manufacturing for an innovative CAR T-cell therapy for the treatment of paediatric acute lymphoblastic leukaemia 17 April 2025 -- London, UK and New...

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

Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe

FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...

Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025

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Kite Presents New Data on Patient Outcomes with CAR T-Cell Therapy at the 7th European CAR T-Cell Meeting, 6-8 February, Strasbourg, France

6 February 2025 -- Stockley Park, UK -- Kite, a Gilead Company, will share four posters that add to the growing body of evidence to support the clinical use of...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 6, 2025

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CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer

Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025

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Cognizant and Gilead Expand Partnership to Drive Greater Value Through Advanced Technology Applications

Cognizant will provide AI-driven solutions to enhance customer service, employee engagement, and business value 30 January 2025 -- New Jersey, US -- Cognizant has announced an expansion of its longstanding relationship...

Category: Biotechnology, Drug Discovery, Logistics, Other, Pharmaceutical
Posted: January 30, 2025

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GILEAD AND LEO PHARMA ENTER INTO STRATEGIC PARTNERSHIP TO ACCELERATE DEVELOPMENT OF ORAL STAT6 PROGRAM WITHPOTENTIAL IN MULTIPLE INFLAMMATORY DISEASES

11 January 2025 – Foster City, California, US and Ballerup, Denmark – Gilead Sciences, Inc. (Nasdaq: GILD) andLEO Pharmatoday announced a strategic partnership to accelerate the development and commercialization of...

Category: Pharmaceutical
Posted: January 13, 2025