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Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. 26 May 2023
Biotechnology
Stockholm-based biotech firm Swedish Orphan Biovitrum has announced that the European Medicines Agency (EMA) has accepted and validated a marketing authorization application for efanesoctocog alfa. 19 May 2023
Pharmaceutical
New guidance has been developed by the European Medicines Agency to help the pharmaceutical industry maintain continuity of supply and prevent shortages. 18 May 2023
Pharmaceutical
A team of German Institute for Quality and Efficiency in Health Care (IQWiG) authors, together with Rita Banzi from the Italian Mario Negri Institute, analyzed the effects of the lack of evidence on orphan drugs at the European and national level. The conclusion is that the need for reform is great. 15 May 2023
Biotechnology
The recent European Commission approval for Sotyktu (deucravacitinib), US pharma major Bristol Myers Squibb’s first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for adults with moderate-to-severe plaque psoriasis (PsO), has elicited comment from a leading data and analytics firm. 11 May 2023
Pharmaceutical
French drugmaker Servier has secured European approval for Tibsovo (ivosidenib) in two indications, making it the first and only IDH1 blocker to be available in the region. 11 May 2023
Biotechnology
Alexion, a subsidiary of Anglo-Swedish pharma major AstraZeneca with a focus on rare diseases, has scored another win in neuromyelitis optica spectrum disorder (NMOSD). 10 May 2023
Biotechnology
A new Fabry disease therapy, PRX-102 (pegunigalsidase alfa), has been given marketing authorization by the European Medicines Agency. 9 May 2023
Pharmaceutical
The European Medicines Agency is considering changing the transparency rules around clinical trials, with a public consultation on the matter now open. 4 May 2023
Biotechnology
The European Commission (EC) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for a number of new lymphoma indications. 3 May 2023
Pharmaceutical
The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting. 28 April 2023
Pharmaceutical
The European Commissiont has issued a long-anticipated set of proposals to reform the legislative framework for medicines in the region. 26 April 2023
Pharmaceutical
Kidney disease specialist Akebia Therapeutics saw its shares lifted over 6% on Monday, following a European approval for Vafseo (vadadustat). 26 April 2023
Pharmaceutical
The European Medicines Agency has provided Johnson & Johnson with its first regulatory approval for Akeega (niraparib/abiraterone acetate). 24 April 2023
Biotechnology
French gene therapy company GenSight Biologics saw its shares crash 69% by close of trading on Friday, and fall a further 10.3% to 0.66 euros in early trading today, after it announced the withdrawal of its European regulatory filing for what could be the first gene therapy for Leber hereditary optic neuropathy (LHON) patients. 24 April 2023
Pharmaceutical
The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials submitted as pivotal evidence in support of marketing authorization applications. 21 April 2023
Biotechnology
The European Commission has granted a marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 21 April 2023
Biotechnology
The European Commission (EC) has approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 18 April 2023
Pharmaceutical
Research from industry analyst GlobalData highlights the significance of the pediatric treatment opportunity for Novartis’ Entresto (sacubitril/valsartan). 18 April 2023
Biotechnology
Moderna and Merck & Co have announced that mRNA-4157/V940 alongside Keytruda (pembrolizumab) has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of high-risk stage III/IV melanoma following complete resection. 11 April 2023
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the publication of the Competitiveness Compass by the European Commission (EC) and the recognition of the role that innovation in life sciences can play in reigniting competitiveness in the European Union (EU). 3 February 2025
Pharmaceutical
As of today, all clinical trials in the European Union (EU), including those that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR). 31 January 2025
Pharmaceutical
The European Commission (EC) has authorized the combination of ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) and Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) to treat HIV-1 infection in adolescents of 12 years of age and older and weighing at least 35 kg who are virologically suppressed. 31 January 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its January 2025 meeting, as well as some biosimilars. 31 January 2025
Biotechnology
The European Commission (EC) has approved Blincyto (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adults with newly-diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 30 January 2025
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
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