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Pharmaceutical
French drug developer Averoa today announced that the European Commission (EC) has granted marketing authorization for Xoanacyl (ferric citrate coordination complex). 16 June 2025
Pharmaceutical
Privately-held Italian pharma company Italfarmaco today revealed that the European Commission (EC) has granted conditional marketing authorization for Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor. 9 June 2025
Pharmaceutical
AstraZeneca has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL). 6 June 2025
Pharmaceutical
The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care. 5 June 2025
Pharmaceutical
The European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA), Swiss pharma giant Roche revealed today 4 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign. 19 May 2025
Pharmaceutical
Vaccines Europe’s response to the Call for Evidence on the European Centre for Disease Prevention and Control evaluation Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). 19 May 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
Biotechnology
Sino-American biotech BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8 May 2025
Pharmaceutical
UK pharma major AstraZeneca today revealed that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. 6 May 2025
Pharmaceutical
The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan). 29 April 2025
Biotechnology
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
Pharmaceutical
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months. 26 April 2025
Pharmaceutical
Draft EU regulatory proposals have been described by the leading European trade body as “sabotage” of the industry. We consider the fallout with Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin. 31 March 2023
Biotechnology
Two years after the US regulator concluded it was necessary to increase label warnings on safety for certain JAK inhibitors, the European Medicines Agency has followed suit. 31 March 2023
Biotechnology
The European Commission (EC) has approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression, US biotech firm Regeneron revealed today. 29 March 2023
Biotechnology
Bristol Myers Squibb’s Sotyktu (deucravacitinib) is continuing to vindicate the company’s decision to favor the drug’s development over Otezla (apremilast). 28 March 2023
Biotechnology
US rare diseases focused biotech Amicus Therapeutics today announced that the European Commission (EC) has granted approval for Pombiliti (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD). 27 March 2023
Biotechnology
French pharma major Sanofi has gained another new indication approval in Europe for its already blockbuster drug Dupixent (dupilumab). 21 March 2023
Pharmaceutical
The trade group European Federation of Pharmaceutical Industries and Associations (EFPIA) has slammed recent new regulations, saying they delay medical research. 20 March 2023
Pharmaceutical
There will be changes impacting drugmakers doing business in Northern Ireland as a result of February’s Windsor Framework agreement between the UK and European Union (EU). 7 March 2023
Biotechnology
The European Commission (EC) has granted full Marketing Authorization for Reblozyl (luspatercept), for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia, US pharma major Bristol Myers Squibb announced on Friday. 4 March 2023
Pharmaceutical
The European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC). 1 March 2023
Pharmaceutical
The European Medicines Agency’s human medicines committee, the CHMP, on Friday recommended the refusal of a marketing authorization for US pharma giant Merck & Co’s Lagevrio (molnupiravir) for the treatment of COVID-19 in adults. 27 February 2023
Biotechnology
At its February meeting, the European Medicines Agency’s human medicines committee CHMP recommended approval of eight novel medicines, one of which is a biosimilar. 24 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate. 22 February 2023
Biotechnology
UK pharma major AstraZeneca today revealed that Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers. 22 February 2023
Pharmaceutical
Global specialist HIV company ViiV Healthcare, which is majority owned by GSK, has been granted marketing authorization by the European Medicines Agency (EMA) for Triumeq PD. 22 February 2023
Biotechnology
The European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. 21 February 2023
Biotechnology
Dutch rare disease specialist Pharming has suffered a setback in the European approval process for its leniolisib, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. 16 February 2023
Biosimilars
Icelandic firm Alvotech and marketing partner German drugmaker STADA Arzneimittel today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab). 9 February 2023
Pharmaceutical
Britain’s AstraZeneca has secured a new European approval for heart med Forxiga (dapagliflozin), an innovative medicine known in the USA as Farxiga. 8 February 2023
Pharmaceutical
Belgian drug major UCB’s shares were up 2% at 77.70 euros this morning, on the news that Fintepla (fenfluramine) oral solution has been approved by the European Commission for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 8 February 2023
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