News and Press Releases

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

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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

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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

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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

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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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Vertex Provides Updates on Multiple Kidney Programs at the American Society of Nephrology (ASN) Annual Kidney Week Congress

New data on povetacicept 80 mg SC Q4 weeks in IgA nephropathy shows mean UPCRreduction from baseline of 66% observed at 48 weeks, associated with stable renalfunction (eGFR) and 63%...

Category: BioManufacturing, Pharmaceutical
Posted: October 28, 2024

Pierre Fabre Laboratories receives European Commission Approval for BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation

Castres, France, August 30, 2024 – Pierre Fabre Laboratories announced today that the European Commission (EC) has approved BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult...

Category:
Posted: September 5, 2024

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Destiny Pharma initiates research to explore XF drug potential for CF

Study to investigate the potential of XF-73 to treat MRSA infection in people with cystic fibrosis 14 August 2024 -- Brighton, UK -- Destiny Pharma, a clinical stage biotechnology company...

Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: August 14, 2024

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Epsilogen announces CTA approval for phase 1b trial of MOv18 IgE in platinum-resistant ovarian cancer

Phase 1b study expected to initiate in H2 2024 Previously reported phase 1 results showed MOv18 IgE to be safe and well-tolerated, with evidence of anti-tumour activity. 8 July 2024...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: July 8, 2024

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