News and Press Releases
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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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) 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
Johnson & Johnson highlights new data, demonstrating long-term sustained disease control in adults living with generalised myasthenia gravis (gMG)
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open label extension phase Up...
Category: Clinical Trials, Other, Pharmaceutical
Posted: April 8, 2025
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ImmunityBio to Host Key Opinion Leader and Investor Meeting to Provide Updates on Clinical Programs and ANKTIVA Commercial Launch
7 April 2025 -- California, US -- ImmunityBio, Inc, a leading immunotherapy company, today announced details about its Investor Day program to be held on Tuesday, April 15, 2025, at...
Category: Drug Discovery, Other, Pharmaceutical
Posted: April 7, 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
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RYBREVANT (amivantamab) plus LAZCLUZE (lazertinib) demonstrates significant overall survival benefit in patients with EGFR-mutated advanced non-small cell lung cancer versus osimertinib
Median overall survival not yet reached with a projected improvement of more than one year versus osimertinib 26 March 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson &...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: March 26, 2025
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Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Combination of complete skin clearance data and favourable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (Pso) treated with...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 10, 2025
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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
Venus Remedies gets Marketing Authorization for anticoagulant ‘Enoxaparin’ from Indonesia
Latest approvals from Indonesia, Southeast Asia’s largest pharma market, to help strengthen company’s regional and global aspirations 10 February 2025 -- Panchkula, India -- Venus Remedies Limited, a leading Indian exporter...
Category: Drug Delivery, Other, Pharmaceutical
Posted: February 10, 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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Fondazione Telethon Submits EU Marketing Authorisation Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Syndrome
3 February 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Marketing Authorization Application (MAA) for the...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other
Posted: February 3, 2025
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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