News and Press Releases
PADCEVTM (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Patients with Resectable Muscle-Invasive Bladder Cancer who are Ineligible for Cisplatin-Based Chemotherapy
Positive opinion is based on data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 22, 2026
Otsuka Pharmaceuticals UK announces MHRA authorisation of new treatment option for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older
The first ribonucleic acid (RNA)-targeted prophylactic therapy for patients with hereditary angioedema (HAE) to be authorised by the MHRA HAE is a rare and potentially life-threatening genetic condition affecting approximately...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 21, 2026
Gallions Wexham Springs Framewood Road Wexham SL3 6PJ
FASENRA approved in US for hypereosinophilic syndrome
14 May 2026 -- Cambridge, UK -- AstraZeneca’s FASENRA (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 14, 2026
Chiesi Receives MHRA Approval for Additional Dosing Regimen of Elfabrio (pegunigalsidase alfa) 2mg/kg administered every-four-weeks in adults stable with an enzyme replacement therapy
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved an additional dosing regimen of 2mg/kg administered every-four-weeks for pegunigalsidase alfa in adults stable with an enzyme replacement therapy...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 14, 2026
AOP Health and VRG Therapeutics Enter Co-Development Partnership for New Immunology Program
12 May 2026 -- Vienna, Austria and Budapest, Hungary -- AOP Health, a global pharmaceutical enterprise group focused on integrated therapies for rare diseases and critical care, today announced a strategic partnership...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: May 12, 2026
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
Epitopea Announces Approval of OVACT Clinical Trial Application for CryptiVax-1001 in Advanced High-Grade Serous Ovarian Cancer
Appoints Leading Oncologist Professor Susana Banerjee of The Royal Marsden as Chief Investigator 23 April 2026 -- Cambridge, UK and Montreal, Canada -- Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, today announced that it has received approval from the UK’s Medicines and Healthcare...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 23, 2026
Salisbury House, Station Road, Cambridge, Cambridgeshire, United Kingdom, CB1 2LA
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Moderna Receives MHRA Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1
The LP.8.1 vaccine is the first commercially licenced mRNA vaccine to be manufactured in the UK at the Moderna Innovation and Technology Centre in Oxfordshire The updated vaccines will be...
Category: Biotechnology, Drug Delivery, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2026
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
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
Data from GNT-018-IDES trial supports feasibility of imlifidase as pretreatment in gene therapy treatment for patients with Crigler–Najjar syndrome who are immune to AAV
Results presented today at ESGCT 2025 10 October 2025 -- Paris, France and Lund, Sweden -- Genethon, a worldwide pioneer and leader in research and development of gene therapy for rare...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 10, 2025
Relief Therapeutics and NeuroX, Successor to MindMaze, Sign Definitive Agreement for Business Combination
Companies sign definitive agreement following previously announced binding term sheet Transaction to create an expanded, SIX-listed, commercial-stage, AI-driven, scalable health tech company Combined company to be renamed MindMaze Therapeutics Holding...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 8, 2025
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
Capital House, 1st Floor, 85 King William Street, London EC4N 7BL
