EMA-regulated pharmaceutical news, drug approvals, and clinical trial updates for the European market.https://novapharmanews.com/en-GBMon, 04 May 2026 22:25:07 GMThttps://novapharmanews.com/eu/news/vanda-pharmaceuticals-nereus-tradipitant-motion-sickness-drug-launch/https://novapharmanews.com/eu/news/vanda-pharmaceuticals-nereus-tradipitant-motion-sickness-drug-launch/Vanda Pharmaceuticals announces commercial availability of NEREUS (tradipitant), the first new prescription motion sickness treatment in over 40 years.Mon, 04 May 2026 21:14:01 GMTnewsDr. Elena Rossihttps://novapharmanews.com/eu/news/takeda-tak-881-phase-3-trial-primary-immunodeficiency-disease-results/https://novapharmanews.com/eu/news/takeda-tak-881-phase-3-trial-primary-immunodeficiency-disease-results/Takeda announces positive topline results for TAK-881, showing pharmacokinetic comparability to HYQVIA in pivotal Phase 2/3 trial for PID patients.Mon, 04 May 2026 21:13:28 GMTnewsOliver Granthttps://novapharmanews.com/eu/news/pulse-biosciences-atrial-fibrillation-treatment-100-percent-success-rate-2026/https://novapharmanews.com/eu/news/pulse-biosciences-atrial-fibrillation-treatment-100-percent-success-rate-2026/Pulse Biosciences achieves 100% procedural success in atrial fibrillation treatment study with 95 evaluable patients at 6 months, presenting data at Heart Rhythm 2026.Mon, 04 May 2026 21:13:07 GMTnewsProf. Marcus Webbhttps://novapharmanews.com/eu/news/sq-innovation-lasix-onyu-subcut-hf-ii-trial-results-heart-failure-2026/https://novapharmanews.com/eu/news/sq-innovation-lasix-onyu-subcut-hf-ii-trial-results-heart-failure-2026/SQ Innovation announces SUBCUT HF II trial results for Lasix ONYU, the first at-home subcutaneous furosemide treatment for heart failure edema, May 9th.Mon, 04 May 2026 21:12:47 GMTnewsOliver Granthttps://novapharmanews.com/eu/news/krystal-biotech-q1-2026-results-vyjuvek-expansion-registrational-studies/https://novapharmanews.com/eu/news/krystal-biotech-q1-2026-results-vyjuvek-expansion-registrational-studies/Krystal Biotech announces Q1 2026 results highlighting VYJUVEK global expansion and two upcoming registrational study readouts for gene therapy pipeline.Mon, 04 May 2026 21:12:24 GMTnewsDr. Lukas Schneiderhttps://novapharmanews.com/eu/news/acurx-dna-pol-iiic-inhibitors-microbiome-preservation-mrsa-escmid-2026/https://novapharmanews.com/eu/news/acurx-dna-pol-iiic-inhibitors-microbiome-preservation-mrsa-escmid-2026/Acurx presents promising data showing DNA pol IIIC inhibitors effectively treat MRSA infections while preserving gut microbiome, addressing key antibiotic concern.Mon, 04 May 2026 21:12:13 GMTnewsProf. Marcus Webbhttps://novapharmanews.com/eu/news/biocryst-navenibart-european-licensing-deal-neopharmed-gentili/https://novapharmanews.com/eu/news/biocryst-navenibart-european-licensing-deal-neopharmed-gentili/BioCryst receives $70M upfront plus milestone payments up to $275M for navenibart licensing agreement with Neopharmed Gentili's Irish affiliate in Europe.Mon, 04 May 2026 21:11:34 GMTnewsCharlotte Meyerhttps://novapharmanews.com/eu/news/biosimulation-market-11-billion-2031-drug-development/https://novapharmanews.com/eu/news/biosimulation-market-11-billion-2031-drug-development/The global biosimulation market will grow 16%+ annually to $11.3 billion by 2031, driven by pharmaceutical companies adopting digital modeling for faster drug development.Mon, 04 May 2026 21:11:01 GMTnewsDr. Lukas Schneiderhttps://novapharmanews.com/eu/news/grin-therapeutics-phase-3-beeline-study-radiprodil-europe-grin-ndd/https://novapharmanews.com/eu/news/grin-therapeutics-phase-3-beeline-study-radiprodil-europe-grin-ndd/GRIN Therapeutics initiates Phase 3 Beeline study in Europe for investigational radiprodil targeting GRIN-NDD, expanding global clinical program.Mon, 04 May 2026 21:10:50 GMTnewsOliver Granthttps://novapharmanews.com/eu/news/fda-approves-langlara-biosimilar-lantus-insulin-lannett-company/https://novapharmanews.com/eu/news/fda-approves-langlara-biosimilar-lantus-insulin-lannett-company/FDA approves LANGLARA (insulin glargine-aldy) as interchangeable biosimilar to Lantus for diabetes treatment in adults and pediatric patients.Mon, 04 May 2026 21:10:15 GMTnewsProf. Marcus Webbhttps://novapharmanews.com/eu/news/vertex-casgevy-gene-therapy-global-expansion-q1-2026-results/https://novapharmanews.com/eu/news/vertex-casgevy-gene-therapy-global-expansion-q1-2026-results/Vertex's CASGEVY, the first approved CRISPR gene therapy, now serves 60,000+ eligible sickle cell disease and beta thalassemia patients across 10 countries.Mon, 04 May 2026 21:09:44 GMTnewsHematology/Blood DisordersSofia Alvarezhttps://novapharmanews.com/eu/news/oncolytics-biotech-pelareorep-durable-responses-ras-mutant-colorectal-cancer/https://novapharmanews.com/eu/news/oncolytics-biotech-pelareorep-durable-responses-ras-mutant-colorectal-cancer/Oncolytics Biotech reports sustained clinical benefit with pelareorep immunotherapy in second-line RAS-mutant MSS colorectal cancer patients.Mon, 04 May 2026 21:09:14 GMTnewsDr. Amina Faroukhttps://novapharmanews.com/eu/news/nuvation-bio-ibtrozi-q1-2026-revenue-ros1-nsclc/https://novapharmanews.com/eu/news/nuvation-bio-ibtrozi-q1-2026-revenue-ros1-nsclc/Nuvation Bio reports $18.5M Q1 2026 revenue for IBTROZI (taletrectinib) with majority of 200 new patients being TKI-naïve ROS1+ NSCLC cases.Mon, 04 May 2026 21:09:05 GMTnewsProf. Marcus Webbhttps://novapharmanews.com/eu/news/swiss-biotech-day-daily-roundup/https://novapharmanews.com/eu/news/swiss-biotech-day-daily-roundup/Swiss Biotech Day 2024 convened industry leaders to discuss emerging technologies, regulatory frameworks, and strategic partnerships shaping the European biotech landscape. Key themes included precision medicine, digital health integration, and investment trends in a competitive global market.Mon, 04 May 2026 08:01:51 GMTnewsbiotechDr. Elena Rossihttps://novapharmanews.com/eu/news/fda-approves-auvelity-mdd-axsome-therapeutics/https://novapharmanews.com/eu/news/fda-approves-auvelity-mdd-axsome-therapeutics/The U.S. Food and Drug Administration (FDA) has approved Auvelity, a novel oral antidepressant developed by Axsome Therapeutics, for the treatment of Major Depressive Disorder (MDD) in adults. This approval represents a significant advancement in the mental health landscape.Mon, 04 May 2026 07:05:54 GMTnewsMajor Depressive Disorder (MDD)Dr. Emily Carterhttps://novapharmanews.com/eu/news/purdue-pharma-shutdown-oxycontin-settlement/https://novapharmanews.com/eu/news/purdue-pharma-shutdown-oxycontin-settlement/Purdue Pharma, the manufacturer of OxyContin, is ceasing operations following a $7.4 billion settlement agreement. This landmark deal aims to address the company's role in the opioid crisis and provide compensation to victims.Mon, 04 May 2026 07:04:18 GMTnewsPainDr. Priya Nandakumarhttps://novapharmanews.com/eu/news/eular-2026-immutep-imp761-phase-1-preview/https://novapharmanews.com/eu/news/eular-2026-immutep-imp761-phase-1-preview/Immutep will present Phase I clinical trial data for its investigational drug IMP761 at the EULAR 2026 Congress. IMP761, a first-in-class LAG-3 agonist antibody, is being developed for the treatment of autoimmune diseases.Mon, 04 May 2026 05:03:13 GMTnewsimmunologyDr. Elena Rossihttps://novapharmanews.com/eu/news/novelty-nobility-agc-biologics-bispecific-antibody-manufacturing-partnership/https://novapharmanews.com/eu/news/novelty-nobility-agc-biologics-bispecific-antibody-manufacturing-partnership/South Korean biotech Novelty Nobility expands manufacturing deal with AGC Biologics to advance bispecific antibody candidate through GMP production in Japan.Mon, 04 May 2026 03:02:58 GMTnewsSofia Alvarezhttps://novapharmanews.com/eu/news/smartee-denti-technology-mandibular-repositioning-eas-congress-2026/https://novapharmanews.com/eu/news/smartee-denti-technology-mandibular-repositioning-eas-congress-2026/Smartee Denti-Technology presents breakthrough mandibular repositioning innovations and European expansion strategy at EAS Congress 2026 in Brussels.Mon, 04 May 2026 03:02:39 GMTnewsSofia Alvarezhttps://novapharmanews.com/eu/articles/purdue-pharma-shutdown-opioid-settlement/https://novapharmanews.com/eu/articles/purdue-pharma-shutdown-opioid-settlement/Purdue Pharma, the manufacturer of OxyContin, is ceasing operations as part of a $7.4 billion settlement to address its role in the opioid crisis. This landmark agreement aims to resolve thousands of lawsuits and redirect company assets towards addiction treatment and prevention.Mon, 04 May 2026 01:06:55 GMTanalysisPain managementDr. Amina Faroukhttps://novapharmanews.com/eu/news/swiss-biotech-day-2026-ai-oncology-microbiome/https://novapharmanews.com/eu/news/swiss-biotech-day-2026-ai-oncology-microbiome/Swiss Biotech Day 2026 in Basel highlights AI in drug discovery, precision oncology, and microbiome therapies, featuring presentations from Evotec, Nvidia, and Ferring Pharmaceuticals.Mon, 04 May 2026 00:03:42 GMTnewsbiotechDr. Elena Rossihttps://novapharmanews.com/eu/news/purdue-pharma-dissolution-approved-opioid-crisis/https://novapharmanews.com/eu/news/purdue-pharma-dissolution-approved-opioid-crisis/Purdue Pharma, the maker of OxyContin, is set to dissolve after a judge approved its criminal sentence. This landmark decision is a significant development in the ongoing legal battles surrounding the opioid crisis.Sun, 03 May 2026 07:05:42 GMTnewsPainDr. Grace Tanhttps://novapharmanews.com/eu/news/auvelity-fda-approval-axsome-therapeutics/https://novapharmanews.com/eu/news/auvelity-fda-approval-axsome-therapeutics/The FDA has approved Auvelity, a groundbreaking oral antidepressant from Axsome Therapeutics, marking a significant advancement in treating major depressive disorder (MDD). This approval introduces a novel mechanism of action for patients seeking effective relief.Sun, 03 May 2026 07:05:33 GMTnewsMajor Depressive Disorder (MDD)Charlotte Meyerhttps://novapharmanews.com/eu/articles/orchard-therapeutics-otl-201-innovation-passport-mps-iiia/https://novapharmanews.com/eu/articles/orchard-therapeutics-otl-201-innovation-passport-mps-iiia/Orchard Therapeutics has secured an Innovation Passport designation from the MHRA for its investigational gene therapy, OTL-201, targeting MPS-IIIA. This marks a significant step in accelerating development and access for patients with Sanfilippo syndrome type A.Sun, 03 May 2026 01:07:57 GMTanalysisMucopolysaccharidosis type IIIA (MPS-IIIA)Dr. Priya Nandakumarhttps://novapharmanews.com/eu/articles/nice-technology-appraisals-oncology-market-access-2024/https://novapharmanews.com/eu/articles/nice-technology-appraisals-oncology-market-access-2024/This article examines the role of NICE Technology Appraisals in shaping market access strategies for innovative oncology drugs, including Pembrolizumab.Sat, 02 May 2026 16:35:06 GMTanalysisoncologyHiroshi Satohttps://novapharmanews.com/eu/articles/mhra-post-brexit-drug-approval-market-analysis-2026/https://novapharmanews.com/eu/articles/mhra-post-brexit-drug-approval-market-analysis-2026/Learn about the MHRA's new drug approval process post-Brexit and its impact on the availability of essential medications like Ozempic for diabetes.Sat, 02 May 2026 16:32:28 GMTanalysisDr. Sarah Mitchellhttps://novapharmanews.com/eu/articles/ema-market-analysis-car-t-cell-therapy-europe-2024/https://novapharmanews.com/eu/articles/ema-market-analysis-car-t-cell-therapy-europe-2024/Discover the latest insights on CAR-T Cell Therapy in Europe, focusing on clinical trials, safety profiles, and market access for hematologic cancers.Sat, 02 May 2026 16:32:16 GMTanalysishematological malignanciesB-cell lymphomaleukemiaDr. Laura Bennetthttps://novapharmanews.com/eu/articles/ema-market-analysis-biosimilar-uptake-eu-2024/https://novapharmanews.com/eu/articles/ema-market-analysis-biosimilar-uptake-eu-2024/This article examines how biosimilar adoption in the EU is reshaping the market landscape for biologics like Adalimumab after patent expirations and under HTA regulations.Sat, 02 May 2026 16:32:03 GMTanalysisbiologicsrare diseasesDr. Emily Carterhttps://novapharmanews.com/eu/articles/ema-conditional-marketing-authorizations-prac-safety-review-2024/https://novapharmanews.com/eu/articles/ema-conditional-marketing-authorizations-prac-safety-review-2024/This article delves into the evolving framework of EMA Conditional Marketing Authorizations and highlights PRAC's safety insights for drug XYZ in cancer therapy.Sat, 02 May 2026 16:31:48 GMTanalysisnovel therapiesadvanced therapiesDr. Yuna Parkhttps://novapharmanews.com/eu/articles/mhra-drug-approval-divergence-market-impact-2026/https://novapharmanews.com/eu/articles/mhra-drug-approval-divergence-market-impact-2026/This article delves into the differences in MHRA drug approval processes for [Drug Name] in [Indication], highlighting their effects on market access and investment strategies in the UK and EU.Sat, 02 May 2026 16:30:55 GMTanalysisSofia Alvarezhttps://novapharmanews.com/eu/articles/mhra-divergence-ema-approval-pathways-eu-market-access-2024/https://novapharmanews.com/eu/articles/mhra-divergence-ema-approval-pathways-eu-market-access-2024/This article explores the key differences between MHRA and EMA regulations, focusing on how they affect market access for drugs like XYZ in the EU.Sat, 02 May 2026 16:30:43 GMTanalysisDr. Sarah Mitchellhttps://novapharmanews.com/eu/news/fda-approves-auvelity-for-major-depressive-disorder/https://novapharmanews.com/eu/news/fda-approves-auvelity-for-major-depressive-disorder/The FDA has granted approval for Auvelity, a new oral antidepressant developed by Axsome Therapeutics, to treat major depressive disorder (MDD) in adults. This marks a significant advancement in mental health treatment, offering a novel mechanism of action and potentially rapid symptom relief.Sat, 02 May 2026 07:06:11 GMTnewsMajor Depressive Disorder (MDD)Matteo Riccihttps://novapharmanews.com/eu/news/synbiotech-microbiome-womens-healthy-aging-vitafoods-2026/https://novapharmanews.com/eu/news/synbiotech-microbiome-womens-healthy-aging-vitafoods-2026/Taiwan-based SynbioTech presents clinical evidence for probiotic solutions targeting women's muscle maintenance, gut health, and metabolic balance at Vitafoods.Sat, 02 May 2026 03:09:23 GMTnewsSofia Alvarezhttps://novapharmanews.com/eu/news/curaleaf-torsten-greif-board-appointment-european-cannabis/https://novapharmanews.com/eu/news/curaleaf-torsten-greif-board-appointment-european-cannabis/Curaleaf Holdings appoints Torsten Greif to its board of directors to strengthen European medical cannabis operations and EU-GMP certified product distribution.Sat, 02 May 2026 03:08:58 GMTnewsCharlotte Meyerhttps://novapharmanews.com/eu/news/pharmaceutical-manufacturing-software-market-787-billion-2030/https://novapharmanews.com/eu/news/pharmaceutical-manufacturing-software-market-787-billion-2030/Pharmaceutical manufacturing software market grows from $3.82B to $4.43B in 2026 with 15.8% CAGR, projected to reach $7.87B by 2030 amid regulatory demands.Sat, 02 May 2026 03:08:38 GMTnewsProf. Marcus Webbhttps://novapharmanews.com/eu/news/goodrx-ozempic-pill-type-2-diabetes-149-monthly/https://novapharmanews.com/eu/news/goodrx-ozempic-pill-type-2-diabetes-149-monthly/GoodRx now provides self-pay access to Novo Nordisk's oral Ozempic for type 2 diabetes patients starting at $149/month nationwide.Sat, 02 May 2026 03:07:04 GMTnewsDr. Elena Rossihttps://novapharmanews.com/eu/articles/auvelity-fda-approval-mdd-treatment/https://novapharmanews.com/eu/articles/auvelity-fda-approval-mdd-treatment/The FDA has approved Auvelity, a novel oral therapy from Axsome Therapeutics, for the treatment of major depressive disorder (MDD). This marks a significant advancement in MDD treatment options.Sat, 02 May 2026 01:08:04 GMTanalysisMajor Depressive DisorderDr. Yuki Tanakahttps://novapharmanews.com/eu/news/plozasiran-tga-approval-australia-fcs/https://novapharmanews.com/eu/news/plozasiran-tga-approval-australia-fcs/Arrowhead Pharmaceuticals has announced the Therapeutic Goods Administration (TGA) approval of REDEMPLO® (plozasiran) in Australia for patients with Familial Chylomicronemia Syndrome (FCS). This landmark decision broadens global access to a crucial treatment for this rare genetic disorder.Sat, 02 May 2026 01:07:15 GMTnewsFamilial Chylomicronemia Syndrome (FCS)Dr. Amina Faroukhttps://novapharmanews.com/eu/news/stoke-therapeutics-zorevunersen-dravet-syndrome-q1-2026-results/https://novapharmanews.com/eu/news/stoke-therapeutics-zorevunersen-dravet-syndrome-q1-2026-results/Stoke Therapeutics prepares Q1 2026 earnings call featuring Zorevunersen, an investigational antisense therapy targeting Dravet syndrome's underlying cause.Fri, 01 May 2026 03:15:54 GMTnewsDr. Lukas Schneiderhttps://novapharmanews.com/eu/news/uniqure-amt-130-gene-therapy-uk-approval-huntingtons-disease/https://novapharmanews.com/eu/news/uniqure-amt-130-gene-therapy-uk-approval-huntingtons-disease/uniQure completes successful UK MHRA pre-submission meeting for AMT-130 Huntington's disease gene therapy, targeting Q3 2026 marketing authorization application.Fri, 01 May 2026 03:15:22 GMTnewsMatteo Riccihttps://novapharmanews.com/eu/news/northwest-biotherapeutics-annalisa-jenkins-dcvax-cancer-vaccine-adviser/https://novapharmanews.com/eu/news/northwest-biotherapeutics-annalisa-jenkins-dcvax-cancer-vaccine-adviser/Northwest Biotherapeutics names Dr. Annalisa Jenkins as Strategic Adviser to advance DCVax dendritic cell cancer vaccine platform with 25+ years biopharma experience.Fri, 01 May 2026 03:15:02 GMTnewsDr. Elena Rossihttps://novapharmanews.com/eu/news/cerus-intercept-blood-system-european-regulatory-review-phase-3-trials/https://novapharmanews.com/eu/news/cerus-intercept-blood-system-european-regulatory-review-phase-3-trials/Cerus Corporation's INTERCEPT Blood System progresses through European regulatory review while Phase 3 RedeS trial readout and new INT200 device submission planned.Fri, 01 May 2026 03:14:50 GMTnewsMatteo Riccihttps://novapharmanews.com/eu/news/bio-rad-q1-2026-ivdr-compliance-costs-european-diagnostics/https://novapharmanews.com/eu/news/bio-rad-q1-2026-ivdr-compliance-costs-european-diagnostics/Bio-Rad reports Q1 2026 financial results highlighting increased costs from EU IVDR compliance and product portfolio rationalization in diagnostics market.Fri, 01 May 2026 03:14:05 GMTnewsProf. Marcus Webbhttps://novapharmanews.com/eu/news/fda-advisory-committee-recommends-astrazeneca-truqap-pten-deficient-prostate-cancer/https://novapharmanews.com/eu/news/fda-advisory-committee-recommends-astrazeneca-truqap-pten-deficient-prostate-cancer/FDA's Oncologic Drugs Advisory Committee recognizes favorable benefit-risk profile for TRUQAP (capivasertib) in PTEN-deficient metastatic prostate cancer treatment.Fri, 01 May 2026 03:13:26 GMTnewsOncology - Prostate CancerDr. Amina Faroukhttps://novapharmanews.com/eu/news/alkeus-gildeuretinol-stargardt-disease-arvo-2026-data/https://novapharmanews.com/eu/news/alkeus-gildeuretinol-stargardt-disease-arvo-2026-data/Alkeus Pharmaceuticals announces clinical data presentation for investigational oral gildeuretinol treating Stargardt disease at ARVO 2026 meeting.Fri, 01 May 2026 03:12:51 GMTnewsDr. Amina Faroukhttps://novapharmanews.com/eu/news/setpoint-medical-multiple-sclerosis-trial-neuroimmune-therapy/https://novapharmanews.com/eu/news/setpoint-medical-multiple-sclerosis-trial-neuroimmune-therapy/SetPoint Medical enrolls first patients in pilot study testing Setpoint System for relapsing-remitting multiple sclerosis treatment with FDA approval.Fri, 01 May 2026 03:12:20 GMTnewsSofia Alvarezhttps://novapharmanews.com/eu/news/emergent-biosolutions-q1-2026-financial-results/https://novapharmanews.com/eu/news/emergent-biosolutions-q1-2026-financial-results/Emergent BioSolutions releases first quarter 2026 financial results, providing insights into the biodefense and pharmaceutical company's performance.Fri, 01 May 2026 03:11:59 GMTnewsDr. Lukas Schneiderhttps://novapharmanews.com/eu/news/telix-tlx101-px-pixlumi-brain-cancer-imaging-european-approval/https://novapharmanews.com/eu/news/telix-tlx101-px-pixlumi-brain-cancer-imaging-european-approval/Telix Pharmaceuticals' TLX101-Px (Pixlumi) glioma imaging drug enters 210-day European regulatory review after MAA acceptance, targeting brain cancer diagnosis.Fri, 01 May 2026 03:11:09 GMTnewsDr. Hannah O'Connorhttps://novapharmanews.com/eu/articles/ema-eu-pharmaceutical-legislation-reform-orphan-drug-market-exclusivity-2026/https://novapharmanews.com/eu/articles/ema-eu-pharmaceutical-legislation-reform-orphan-drug-market-exclusivity-2026/This article examines how recent EU pharmaceutical legislation reforms could reshape market exclusivity for orphan drugs, affecting access to treatments for rare diseases.Fri, 01 May 2026 01:42:03 GMTanalysisOrphan DiseasesRare DiseasesDr. Yuki Tanakahttps://novapharmanews.com/eu/articles/ema-market-analysis-antibody-drug-conjugates-breast-cancer-2025/https://novapharmanews.com/eu/articles/ema-market-analysis-antibody-drug-conjugates-breast-cancer-2025/This article compares Enhertu and Trodelvy, two leading antibody-drug conjugates, in their effectiveness for breast cancer treatment in the EU market.Fri, 01 May 2026 01:40:01 GMTanalysisoncologybreast cancerDr. Natalie Hughes