News and Press Releases
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
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Cyclana Bio granted Health Research Authority approval and recruits first patients for clinical observational study in endometriosis
UK NHS grants HRA/REC approval for PEMP study with Peterborough and Cambridge hospitals Clinical observational study investigating underlying biology of endometriosis aims to uncover causal mechanisms and new druggable targets...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 19, 2026
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
Ojemda approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration
New treatment option for rare, life-altering pediatric brain tumors Less than 10% of new medicine approvals over the past five years have focused on pediatric diseases; Ojemda (tovorafenib) represents a...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 22, 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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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
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STADA and Bio-Thera receive European Marketing Authorization for Gotenfia, a Biosimilar to Simponi
European Commission grants approval for Gotenfia, a golimumab biosimilar to Simponi that was developed by Bio-Thera and will be marketed by STADA Launch preparations are underway to bring the second...
Category: BioManufacturing, Drug Discovery, Manufacturing and Packing, Other, Pharmaceutical
Posted: February 13, 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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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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Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Induction Trial Results in Participants With and Without Prior Inadequate Response to Advanced Therapies
50 mg dose of once-daily obefazimod achieved clinically meaningful improvements, across all endpoints, regardless of prior inadequate response to advanced therapies (AT-IR) 50mg dose demonstrated clinically meaningful improvements in clinical...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 6, 2025
argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: June 20, 2025
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Northern Gritstone invests in Manchester spinout Apini
Northern Gritstone has committed £1.8 million to Apini, a spinout from the University of Manchester Apini is a novel small molecule therapeutic programme for the treatment of multiple chronic inflammatory...
Category: Biotechnology, Other, Pharmaceutical
Posted: June 11, 2025
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European Commission approves TREMFYA (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
TREMFYA (guselkumab) induction therapy administered either intravenously (GALAXI 2 and 3) or subcutaneously (GRAVITI) achieved the co-primary endpoints of clinical remissiona and endoscopic responseb at Week 12 compared to placebo...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 7, 2025
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Leqembi® (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorised in the European Union
In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 16, 2025
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting Phase 3 CEPHEUS study shows significant...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 7, 2025
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