News and Press Releases
Johnson & Johnson receives CHMP positive opinion for AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
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ALK receives positive CHMP opinion for EURneffy 1mg (nasal adrenaline spray) for emergency anaphylaxis treatment in children (≥15kg)
30 January 2026 -- Hørsholm – Denmark -- Today ALK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World
30 January 2026 -- Incheon, Korea -- Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB15, a biosimilar to...
Category: Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria
Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies showing Dupixent significantly...
Category: Drug Discovery, Other, Pharmaceutical
Posted: November 25, 2025
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SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting
20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025
European Marketing Application for AVT23, a Proposed Biosimilar to Xolair (omalizumab), Accepted by the European Medicines Agency
6 October 2025 -- London, UK and Reykjavik, Iceland -- Advanz Pharma Holdco Limited, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: October 6, 2025
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Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron
Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE (Aflibercept-mrbb) Pending litigation at the U.S. District Court for the Northern District of West Virginia...
Category: Logistics, Other, Pharmaceutical
Posted: October 2, 2025
Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 11, 2025
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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New Anthem from Girl Band Raises Awareness of Type1 Diabetes After Research Highlights Silent Struggle
Recent research from Sanofi highlights the significant impact of Type 1 Diabetes on those living with the condition The song, “Rise Up,” shares their experiences of living with the condition...
Category: Other, Pharmaceutical
Posted: May 29, 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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Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 18, 2025
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Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD
New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma Itepekimab expanding into chronic rhinosinusitis along with...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025
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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