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
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
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
IMAAVY (nipocalimab)▼shows over two years of sustained disease control in a broad population with generalised myasthenia gravis (gMG)
Through 120 weeks of follow-up, nipocalimab delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ Patients achieving sustained minimal symptom expression (MSE)...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 22, 2026
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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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European Commission approves AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)
Niraparib and abiraterone acetate regimen demonstrates clinically meaningful delay in disease progression, nearly halving the risk of progression or death, with an early trend toward improved overall survival versus standard...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 9, 2026
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer
Combination demonstrates deep PSA responses and favorable safety profile with plans to advance into Phase 3 Data highlight the potential of this first-in-class next-generation T-cell engager to expand the role...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 26, 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
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
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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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
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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Johnson & Johnson Launches First Daily Disposable Toric Contact Lens Designed to Deliver on the Specific Needs of Low and High Astigmatic Patients in United Kingdom and Ireland (UKI)
World’s #1 Selling Contact Lens Brand ACUVUE Brings Pioneering Innovation For Astigmatic Patients, Providing Visual Clarity And Comfort The First Toric Lens to have an Optimised Design according to Cylinder...
Category: Drug Delivery, Other, Pharmaceutical
Posted: September 4, 2025
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
iOnctura commences randomized Phase I/II study in non-small cell lung cancer
First patient dosed in study investigating roginolisib + dostarlimab +/- docetaxel in patients with NSCLC who have progressed on prior immunotherapy/chemo Study will evaluate safety of the combination and explore...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 8, 2025
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