EMA Regulatory News
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Pharmaceutical
The European Shortages Monitoring Platform (ESMP) is now live, with the full scope of functionalities. 29 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA). 23 January 2025
Biotechnology
French pharma giant Sanofi has secured European Union approval for Sarclisa (isatuximab) for certain people with newly diagnosed multiple myeloma. 22 January 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Lazcluze (lazertinib), in combination with Rybrevant amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. 21 January 2025
Biotechnology
The European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, UK pharma major GSK announced today. 20 January 2025
Biotechnology
Germany’s Formycon and its licensing partner Klinge Biopharma have announced that the European Commission (EC) has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama. 20 January 2025
Pharmaceutical
The European Medicines Agency (EMA) today revealed that, in 2024, it recommended 114 medicines for marketing authorization. Of these, 46 had a new active substance which had never been authorized in the European Union (EU) before. 16 January 2025
Biosimilars
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
Biotechnology
Johnson & Johnson has secured European approval for Rybrevant (amivantamab) in combination with Lazcluze (lazertinib), as a first-line treatment for certain patients with non-small cell lung cancer (NSCLC). 30 December 2024
Biotechnology
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Biotechnology
US healthcare giant Johnson & Johnson has announced the submission of a Type II variation application to the European Medicines Agency (EMA). 18 December 2024
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for six biosimilar medicines at its December meeting. 14 December 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended another batch medicines for approval at its December 2024 meeting, bringing the total number of medicines recommended for approval in 2024 to 114. 13 December 2024
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abello announced that its European regulatory filing for Acarizax (house dust mite sublingual allergy immunotherapy tablet) in young children aged five to 11 has been approved by the health authorities in 21 European Union (EU countries via a type II variation procedure. 12 December 2024
Pharmaceutical
Minoryx Therapeutics, a Spanish biotech specializing in therapies for orphan CNS disorders, will submit for European approval for leriglitazone by the middle of next year. 11 December 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The European Shortages Monitoring Platform (ESMP) is now live, with the full scope of functionalities. 29 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA). 23 January 2025
Biotechnology
French pharma giant Sanofi has secured European Union approval for Sarclisa (isatuximab) for certain people with newly diagnosed multiple myeloma. 22 January 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Lazcluze (lazertinib), in combination with Rybrevant amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. 21 January 2025
Biotechnology
The European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, UK pharma major GSK announced today. 20 January 2025
Biotechnology
Germany’s Formycon and its licensing partner Klinge Biopharma have announced that the European Commission (EC) has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama. 20 January 2025
Pharmaceutical
The European Medicines Agency (EMA) today revealed that, in 2024, it recommended 114 medicines for marketing authorization. Of these, 46 had a new active substance which had never been authorized in the European Union (EU) before. 16 January 2025
Biosimilars
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
Biotechnology
Johnson & Johnson has secured European approval for Rybrevant (amivantamab) in combination with Lazcluze (lazertinib), as a first-line treatment for certain patients with non-small cell lung cancer (NSCLC). 30 December 2024
Biotechnology
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Biotechnology
US healthcare giant Johnson & Johnson has announced the submission of a Type II variation application to the European Medicines Agency (EMA). 18 December 2024
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for six biosimilar medicines at its December meeting. 14 December 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended another batch medicines for approval at its December 2024 meeting, bringing the total number of medicines recommended for approval in 2024 to 114. 13 December 2024
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abello announced that its European regulatory filing for Acarizax (house dust mite sublingual allergy immunotherapy tablet) in young children aged five to 11 has been approved by the health authorities in 21 European Union (EU countries via a type II variation procedure. 12 December 2024
Pharmaceutical
Minoryx Therapeutics, a Spanish biotech specializing in therapies for orphan CNS disorders, will submit for European approval for leriglitazone by the middle of next year. 11 December 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
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