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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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
Enterprise Therapeutics achieves primary efficacy outcome in Phase 2 clinical trial for cystic fibrosis with novel inhaled ENaC blocker ETD001
First investigational inhaled ENaC blocker to deliver clinically relevant and statistically significant change in lung function compared to placebo Inhaled therapeutic designed to treat the 10% of people with cystic...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 12, 2026
Sussex Innovation Centre, University of Sussex, Science Park Square, Falmer, Brighton, BN1 9SB, UK
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
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Santhera Announces Approval in Canada for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD...
Category: Other, Pharmaceutical
Posted: October 3, 2025
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Bavarian Nordic launches VIMKUNYA in the UK for the Prevention of Chikungunya, for individuals aged 12 years and older
3 September 2025 -- London, UK -- Bavarian Nordic A/S announced today the official UK launch of the VIMKUNYA® chikungunya vaccine (recombinant, absorbed). This follows the recent approval by the...
Category: Drug Discovery, Other, Pharmaceutical
Posted: September 3, 2025
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Leqembi ▼ (lecanemab) proposed Marketing Authorisation Variation for monthly intravenous maintenance dosing for the treatment of early Alzheimer’s disease in the UK is validated for evaluation by the MHRA
Proposed intravenous maintenance dosing application to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult UK patients after initial 18 months of treatment The...
Category: Other, Pharmaceutical
Posted: April 30, 2025
Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma
Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7 Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed UK...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 17, 2025
Moderna’s UK Manufacturing Facility Receives Manufacturing Licence from the MHRA
Milestone marks a pivotal step toward producing mRNA vaccines in the UK in 2025 15 April 2025 – London, UK – ACCESS WIRE – Moderna, Inc. (NASDAQ: MRNA) today announced...
Category: Manufacturing and Packing
Posted: April 15, 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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Vertex Announces UK MHRA Approval of ALYFTREK (Deutivacaftor/Tezacaftor/Vanzacaftor), a Once-Daily Next-in-Class CFTR Modulatorfor the Treatment of Cystic Fibrosis
Deutivacaftor/tezacaftor/vanzacaftor approved for people with cystic fibrosis 6 years and older with at least one responsive mutation in the CFTR gene, including additional mutations not previously approved with other CFTR...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 7, 2025
Boehringer Ingelheim and partners start clinical development of a first-in-class, inhaled gene therapy for people with cystic fibrosis
Ingelheim, Germany – Boehringer Ingelheim, IP Group, the UK Respiratory Gene Therapy Consortium (GTC)1 and OXB,1 today announce the start of LENTICLAIRTM 1, a Phase I/II trial of BI 3720931,...
Category: Biotechnology
Posted: February 24, 2025
Glox Therapeutics Awarded Share of £3M Collaborative Discovery Programme Funding from Cystic Fibrosis Antimicrobial Resistance Syndicate
£500K grant to advance discovery and development of effective precision antibiotics targeting antimicrobial-resistant lung infections in people with cystic fibrosis Programme delivered by CF AMR Syndicate offers cross-sector collaboration and...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 2025
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UK’s MHRA grants Promising Innovative Medicine designation to argenx’ investigational therapy, subcutaneous efgartigimod alfa for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)
28 November 2024 -- Gerrards Cross, UK -- argenx, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, confirmed today that its investigational...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: November 28, 2024
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CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...
Category: Clinical Trials
Posted: November 20, 2024
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