News and Press Releases
Chiesi Completes Clinical Development Program for Carbon-Minimal Pressurized Metered-Dose Inhalers (pMDIs), Paving the Way for Regulatory Submissions
Successfully completed the TRECOS Phase III study, supporting the long-term safety of Chiesi’s carbon minimal pressurized metered dose inhaler (pMDI) platform Aiming to become the first pharmaceutical company to transition...
Category: Clinical Trials, Drug Delivery, Other, Pharmaceutical
Posted: September 26, 2025
Terumo Blood and Cell Technologies Supports Expanded Access to Rare Disease Therapies in Latin America
Regulatory approvals in 14 countries expand treatment options for sickle cell disease, Guillain-Barré syndrome and myasthenia gravis Approvals align with the historic World Health Assembly resolution on rare diseases. 16...
Category: Biotechnology, Drug Delivery, Other, Pharmaceutical
Posted: September 16, 2025
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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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
Chiesi partners with Wirral Primary Care Collaborative to advance early detection of undiagnosed COPD
It is estimated that up to 5,000 people are living with undiagnosed COPD on the Wirral, where prevalence is more than 40% higher than the national average COPD is a...
Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 2025
Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of...
Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 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
Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia. 3 April...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 3, 2025
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
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
PacBio and Radboud UMC Announce Remarkable Study Results Using HiFi Long Read Sequencing to Help Advance Rare Disease Diagnostics
14 January 2025 – Menlo Park, California US – PacBio (NASDAQ: PACB), a leading provider of highly accurate long-read sequencing solutions, announced a significant publication from Radboud University Medical Center...
Category:
Posted: January 16, 2025
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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