News and Press Releases
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
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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Celltrion opens new UK headquarters in Uxbridge, UK
New office located in the heart of Uxbridge underscores Celltrion’s long-term business commitment in the UK 17 June 2025 -- London, UK -- Celltrion UK has officially opened its new...
Category: Clinical Trials, Drug Discovery, Manufacturing and Packing, Other, Pharmaceutical
Posted: June 17, 2025
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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European Commission approves subcutaneous RYBREVANT▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation European Commission (EC) approval based on positive...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 7, 2025
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TREMFYA (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease
Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 28 March 2025 -- Beerse, Belgium -- Johnson & Johnson today announced that...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 28, 2025
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older
Brexpiprazole’s indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older Approval follows a positive Committee for Medicinal Products for Human Use...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 13, 2025
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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
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European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 2025
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Exclusive UniSafe® distribution agreement between Owen Mumford and NIPRO exceeds expectations in Japan with new biosimilar launch
6 December 2024 - Oxford, UK – Owen Mumford, a global leader in medical devices, is pleased to announce that its exclusive agreement with Osaka-based NIPRO CORPORATION (NIPRO) to distribute...
Category: Drug Delivery, Manufacturing and Packing
Posted: December 6, 2024
Outlook Therapeutics Announces NICE Recommendation of LYTENAV (bevacizumab gamma) for the Treatment of Wet AMD
First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025 LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD...
Category:
Posted: December 6, 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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
OKYO Pharma Announces Start of Phase 2 Clinical Trial to Treat Patients with Neuropathic Corneal Pain
Neuropathic corneal pain (NCP) is listed in the National Organization for Rare Disorders (NORD) as an orphan disease OKYO is the first company to have an IND application granted by...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 16, 2024
