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
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
CPHI Americas 2026 unveils keynote speakers tackling pharma’s toughest challenges
11 May 2026 -- Pennsylvania, US -- Informa Markets has announced its keynote speaker line-up for CPHI Americas 2026 (June 2–4), bringing together more than 80 industry thought leaders, including...
Category: Biotechnology, Other, Pharmaceutical
Posted: May 11, 2026
U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder
29 April 2026 -- California, US -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 29, 2026
U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 20, 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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Tozorakimab met primary endpoint in both OBERON and TITANIA Phase III trials in patients with COPD
First-ever IL-33-targeting biologic to demonstrate statistically significant and highly clinically meaningful reductions in COPD exacerbations in two replicate Phase III clinical trials 27 March 2026 -- Cambridge, UK -- Positive...
Category: Clinical Trials, Drug Discovery, Other, 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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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
Recipharm expands manufacturing to meet demanding FDA requirements
Established a new, dedicated non-bacterial beta-lactam manufacturing facility in response to FDA guidance Secured a strategic partnership with an innovative biopharma company seeking rapid regulatory compliance Developed a scalable platform...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 26, 2026
Levicept Announces FDA Acceptance of IND Application for LEVI-04, a Potentially Disease-Modifying Treatment for Osteoarthritis
20 January 2026 -- Sandwich, UK -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the US Food and...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026
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
