Global pharmaceutical news, drug approvals, and regulatory updates across FDA, EMA, and NMPA markets.https://novapharmanews.com/enMon, 04 May 2026 22:25:13 GMThttps://www.rssboard.org/rss-specificationhttps://novapharmanews.com/apac/news/xtalpi-pep08-prmt5-inhibitor-phase-1-cancer-trial-enrollment/https://novapharmanews.com/apac/news/xtalpi-pep08-prmt5-inhibitor-phase-1-cancer-trial-enrollment/XtalPi and PharmaEngine's AI-discovered PRMT5 inhibitor PEP08 starts Phase I solid tumor trial, marking major milestone in synthetic lethality cancer treatment.Mon, 04 May 2026 21:17:29 GMTnewsapacKenji Watanabehttps://novapharmanews.com/apac/news/spontan-phase-ii-data-10-minute-onset-fda-requirements-erectile-dysfunction/https://novapharmanews.com/apac/news/spontan-phase-ii-data-10-minute-onset-fda-requirements-erectile-dysfunction/SPONTAN Phase II interim results demonstrate 10-minute median onset versus 60 minutes for oral vardenafil, meeting FDA pharmacokinetic requirements.Mon, 04 May 2026 21:17:19 GMTnewsapacDr. Grace Tanhttps://novapharmanews.com/apac/news/ironwood-pharmaceuticals-short-bowel-syndrome-tpn-survey-ddw-2026/https://novapharmanews.com/apac/news/ironwood-pharmaceuticals-short-bowel-syndrome-tpn-survey-ddw-2026/Ironwood Pharmaceuticals presents DDW 2026 survey findings highlighting unmet needs in total parenteral nutrition therapy for short bowel syndrome patients.Mon, 04 May 2026 21:16:57 GMTnewsapacHiroshi Satohttps://novapharmanews.com/apac/news/edwards-lifesciences-resilia-tissue-10-year-commence-trial-results/https://novapharmanews.com/apac/news/edwards-lifesciences-resilia-tissue-10-year-commence-trial-results/Edwards Lifesciences announces 10-year COMMENCE trial data demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.Mon, 04 May 2026 21:16:22 GMTnewsapacHiroshi Satohttps://novapharmanews.com/apac/news/novo-nordisk-wegovy-china-launch-eli-lilly-obesity-market/https://novapharmanews.com/apac/news/novo-nordisk-wegovy-china-launch-eli-lilly-obesity-market/Novo Nordisk secures first-mover advantage launching Wegovy in China ahead of Eli Lilly's competing obesity drug, targeting massive untapped market opportunity.Mon, 04 May 2026 21:16:20 GMTnewsapacObesity/Weight ManagementArjun Menonhttps://novapharmanews.com/apac/news/arrowhead-pharmaceuticals-tga-approval-redemplo-plozasiran-australia-fcs/https://novapharmanews.com/apac/news/arrowhead-pharmaceuticals-tga-approval-redemplo-plozasiran-australia-fcs/Arrowhead Pharmaceuticals gains Australian TGA approval for REDEMPLO (plozasiran), expanding global access for familial chylomicronemia syndrome patients.Mon, 04 May 2026 21:15:28 GMTnewsapacDr. Priya Sharmahttps://novapharmanews.com/apac/news/biomarin-palynziq-fda-approval-adolescent-pku-patients/https://novapharmanews.com/apac/news/biomarin-palynziq-fda-approval-adolescent-pku-patients/BioMarin announces FDA approval of PALYNZIQ for adolescents 12+ with phenylketonuria (PKU), expanding treatment options for rare genetic disorder patients.Mon, 04 May 2026 21:15:04 GMTnewsapacDr. Mei Linhttps://novapharmanews.com/apac/news/rois-us-expansion-global-cdmo-fda-approval-injectable-manufacturing/https://novapharmanews.com/apac/news/rois-us-expansion-global-cdmo-fda-approval-injectable-manufacturing/ROIS establishes US operations as global CDMO with FDA, EMA, and other major regulatory approvals for end-to-end injectable drug manufacturing services.Mon, 04 May 2026 21:14:55 GMTnewsapacArjun Menonhttps://novapharmanews.com/apac/news/fda-approves-travere-filspari-fsgs-treatment-adults-children/https://novapharmanews.com/apac/news/fda-approves-travere-filspari-fsgs-treatment-adults-children/Travere Therapeutics receives FDA approval for FILSPARI to reduce proteinuria in FSGS patients aged 8 and older, expanding rare kidney disease treatment options.Mon, 04 May 2026 21:14:09 GMTnewsapacIsabella Cruzhttps://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 GMTnewseuDr. 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 GMTnewseuOliver 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 GMTnewseuProf. 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 GMTnewseuOliver 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 GMTnewseuDr. 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 GMTnewseuProf. 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 GMTnewseuCharlotte 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 GMTnewseuDr. 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 GMTnewseuOliver 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 GMTnewseuProf. 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 GMTnewseuHematology/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 GMTnewseuDr. 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 GMTnewseuProf. Marcus Webbhttps://novapharmanews.com/us/news/crispr-therapeutics-casgevy-global-approvals-60000-patients/https://novapharmanews.com/us/news/crispr-therapeutics-casgevy-global-approvals-60000-patients/CRISPR Therapeutics reports CASGEVY now approved in 10 countries for severe sickle cell disease and beta thalassemia, reaching over 60,000 eligible patients worldwide.Mon, 04 May 2026 21:08:28 GMTnewsusHematology/Blood DisordersDr. Sarah Mitchellhttps://novapharmanews.com/us/news/clene-cnm-au8-fda-accelerated-approval-pathway-als-treatment/https://novapharmanews.com/us/news/clene-cnm-au8-fda-accelerated-approval-pathway-als-treatment/FDA confirms Clene's CNM-Au8 ALS drug can proceed via accelerated approval pathway using neurofilament light biomarker data, with NDA filing expected Q3 2026.Mon, 04 May 2026 21:07:56 GMTnewsusJames Chen, PharmDhttps://novapharmanews.com/us/news/atossa-therapeutics-fda-rare-pediatric-disease-designation-z-endoxifen-mccune-albright-syndrome/https://novapharmanews.com/us/news/atossa-therapeutics-fda-rare-pediatric-disease-designation-z-endoxifen-mccune-albright-syndrome/Atossa Therapeutics gains FDA Rare Pediatric Disease designation for (Z)-endoxifen treating McCune-Albright syndrome, qualifying for Priority Review Voucher.Mon, 04 May 2026 21:07:47 GMTnewsusJames Chen, PharmDhttps://novapharmanews.com/us/news/mbiota-elemental-ibs-treatment-ddw-2026-clinical-trial/https://novapharmanews.com/us/news/mbiota-elemental-ibs-treatment-ddw-2026-clinical-trial/New clinical trial data validates mBIOTA Elemental as effective IBS therapeutic, showing symptom improvement across all three IBS subtypes at DDW 2026.Mon, 04 May 2026 21:07:06 GMTnewsusDr. Sarah Mitchellhttps://novapharmanews.com/us/news/novartis-fabhalta-health-canada-approval-c3g-treatment/https://novapharmanews.com/us/news/novartis-fabhalta-health-canada-approval-c3g-treatment/Health Canada approves Novartis' Fabhalta (iptacopan) oral treatment for adults with complement 3 glomerulopathy, offering new hope for rare kidney disease patients.Mon, 04 May 2026 21:06:46 GMTnewsusDr. Sarah Mitchellhttps://novapharmanews.com/us/news/asco-2026-cellectar-waldenstrom-macroglobulinemia/https://novapharmanews.com/us/news/asco-2026-cellectar-waldenstrom-macroglobulinemia/Cellectar Biosciences will present CLOVER WaM (iopofosine I 131) data at ASCO 2026, focusing on efficacy subset data in relapsed/refractory Waldenström macroglobulinemia.Mon, 04 May 2026 21:06:45 GMTnewsusgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/alpha-tau-alpha-dart-pancreatic-cancer-trials-ddw-2026/https://novapharmanews.com/us/news/alpha-tau-alpha-dart-pancreatic-cancer-trials-ddw-2026/Alpha Tau reports 100% local disease control with Alpha DaRT device in heavily pre-treated pancreatic cancer patients with favorable safety profile.Mon, 04 May 2026 21:06:20 GMTnewsusPancreatic Cancer/OncologyDr. Laura Bennetthttps://novapharmanews.com/us/news/cytokinetics-aficamten-phase-3-trial-results-non-obstructive-hypertrophic-cardiomyopathy-may-2026/https://novapharmanews.com/us/news/cytokinetics-aficamten-phase-3-trial-results-non-obstructive-hypertrophic-cardiomyopathy-may-2026/Cytokinetics announces topline results from pivotal ACACIA-HCM Phase 3 trial of aficamten for non-obstructive hypertrophic cardiomyopathy on May 5, 2026.Mon, 04 May 2026 21:05:49 GMTnewsusDr. Sarah Mitchellhttps://novapharmanews.com/us/news/inflarx-izicopan-reactive-metabolite-liver-safety-study/https://novapharmanews.com/us/news/inflarx-izicopan-reactive-metabolite-liver-safety-study/InflaRx reports favorable safety data for Izicopan showing low reactive metabolite formation in human liver microsomes, reducing bioactivation risks.Mon, 04 May 2026 21:05:22 GMTnewsusDr. Laura Bennetthttps://novapharmanews.com/us/news/macrogenics-expands-zynyz-royalty-agreement-sagard-healthcare/https://novapharmanews.com/us/news/macrogenics-expands-zynyz-royalty-agreement-sagard-healthcare/MacroGenics expands its ZYNYZ royalty purchase agreement with Sagard Healthcare Partners, providing additional funding for the cancer immunotherapy drug.Mon, 04 May 2026 21:05:13 GMTnewsusDr. Laura Bennetthttps://novapharmanews.com/us/news/akebia-vadadustat-mortality-reduction-kidney-disease-jasn-study/https://novapharmanews.com/us/news/akebia-vadadustat-mortality-reduction-kidney-disease-jasn-study/Akebia Therapeutics announces Vadadustat post-hoc analysis published in JASN shows statistically significant reduction in mortality and hospitalization for kidney disease patients.Mon, 04 May 2026 21:04:53 GMTnewsusDr. Natalie Hugheshttps://novapharmanews.com/us/news/inflarx-izicopan-favorable-liver-metabolism-safety-profile-2026/https://novapharmanews.com/us/news/inflarx-izicopan-favorable-liver-metabolism-safety-profile-2026/InflaRx announces positive pre-clinical data showing low reactive metabolite formation for izicopan in human liver microsomes, supporting drug safety profile.Mon, 04 May 2026 21:04:22 GMTnewsusMichael Riverahttps://novapharmanews.com/us/news/celcuity-gedatolisib-phase-3-viktoria-1-trial-pik3ca-mutant-cancer/https://novapharmanews.com/us/news/celcuity-gedatolisib-phase-3-viktoria-1-trial-pik3ca-mutant-cancer/Celcuity's VIKTORIA-1 Phase 3 trial shows clinically meaningful progression-free survival improvement with gedatolisib in PIK3CA mutant patients.Mon, 04 May 2026 21:03:26 GMTnewsusOncologyDr. Emily Carterhttps://novapharmanews.com/us/news/fda-approves-langlara-interchangeable-biosimilar-lantus-insulin-lannett/https://novapharmanews.com/us/news/fda-approves-langlara-interchangeable-biosimilar-lantus-insulin-lannett/FDA approves LANGLARA as interchangeable biosimilar to Lantus insulin glargine, marking Lannett Company's entry into diabetes treatment market through Lanexa Biologics.Mon, 04 May 2026 21:02:53 GMTnewsusDiabetes/EndocrinologyDr. Emily Carterhttps://novapharmanews.com/us/news/fda-approves-guardant360-cdx-companion-diagnostic-pfizer-veppanu-breast-cancer/https://novapharmanews.com/us/news/fda-approves-guardant360-cdx-companion-diagnostic-pfizer-veppanu-breast-cancer/Guardant Health receives FDA approval for blood-based companion diagnostic to identify patients eligible for VEPPANU treatment in advanced breast cancer with ESR1 mutations.Mon, 04 May 2026 21:02:14 GMTnewsusMichael Riverahttps://novapharmanews.com/us/news/fda-approves-incyte-jakafi-xr-extended-release-myelofibrosis/https://novapharmanews.com/us/news/fda-approves-incyte-jakafi-xr-extended-release-myelofibrosis/Incyte receives FDA approval for once-daily Jakafi XR (ruxolitinib) extended-release tablets for myelofibrosis, polycythemia vera, and GVHD treatment.Mon, 04 May 2026 21:01:50 GMTnewsusHematology/OncologyDr. Priya Nandakumarhttps://novapharmanews.com/us/news/arvinas-veppanu-vepdegestrant-fda-approval-first-protac-drug-esr1-breast-cancer/https://novapharmanews.com/us/news/arvinas-veppanu-vepdegestrant-fda-approval-first-protac-drug-esr1-breast-cancer/Arvinas' VEPPANU becomes the first FDA-approved PROTAC drug for ESR1-mutated, ER+/HER2- advanced breast cancer, marking a breakthrough in protein degradation therapy.Mon, 04 May 2026 21:01:28 GMTnewsusOncology - Advanced Breast CancerDr. Laura Bennetthttps://novapharmanews.com/us/news/excipient-world-conference-daily-roundup/https://novapharmanews.com/us/news/excipient-world-conference-daily-roundup/The Excipient World Conference 2026 highlighted major advances in pharma excipients, including innovations in drug delivery, regulatory compliance strategies, and sustainable formulation technologies shaping the future of pharmaceutical development.Mon, 04 May 2026 20:02:13 GMTnewsusgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/APHL-2026-annual-meeting-day-1-highlights/https://novapharmanews.com/us/news/APHL-2026-annual-meeting-day-1-highlights/Day 1 of the APHL 2026 Annual Meeting featured discussions on innovative diagnostic approaches and collaborative strategies in public health laboratory science.Mon, 04 May 2026 16:00:35 GMTnewsusgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/aphl-2026-day-1-roundup/https://novapharmanews.com/us/news/aphl-2026-day-1-roundup/Day 1 of APHL 2026 focused on innovations in public health laboratory practices and emerging technologies. The opening keynote addressed the importance of data-driven decision-making in public health.Mon, 04 May 2026 12:00:31 GMTnewsusgeneralDr. Sarah Mitchellhttps://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 GMTnewseubiotechDr. Elena Rossihttps://novapharmanews.com/apac/news/fda-approves-auvelity-new-mdd-treatment/https://novapharmanews.com/apac/news/fda-approves-auvelity-new-mdd-treatment/The FDA has approved Auvelity, a new oral antidepressant combining bupropion and dextromethorphan, for the treatment of major depressive disorder (MDD) in adults. Manufactured by Axsome Therapeutics, this approval marks a significant advancement in MDD treatment options.Mon, 04 May 2026 07:08:39 GMTnewsapacMajor Depressive Disorder (MDD)Dr. Hannah O'Connorhttps://novapharmanews.com/apac/news/sun-pharma-organon-partnership-india/https://novapharmanews.com/apac/news/sun-pharma-organon-partnership-india/Sun Pharma has announced a strategic partnership with Organon to commercialize five of Organon's established products across India. This collaboration aims to leverage Sun Pharma's extensive network to improve patient access to vital treatments.Mon, 04 May 2026 07:08:09 GMTnewsapacwomen's health, spasticity, rheumatoid arthritisDr. Yuna Parkhttps://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 GMTnewseuMajor 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 GMTnewseuPainDr. Priya Nandakumarhttps://novapharmanews.com/us/news/fda-approves-palazestrant-pfizer-arvinas-breast-cancer-drug/https://novapharmanews.com/us/news/fda-approves-palazestrant-pfizer-arvinas-breast-cancer-drug/The U.S. Food and Drug Administration (FDA) has granted approval for palazestrant, a novel breast cancer treatment developed by Pfizer and Arvinas. This decision comes despite some concerns raised about the drug's clinical trial data, marking a significant development in breast cancer therapy.Mon, 04 May 2026 07:02:27 GMTnewsusbreast cancerDr. Natalie Hugheshttps://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 GMTnewseuimmunologyDr. Elena Rossihttps://novapharmanews.com/us/news/thma-pharmacy-growth-priorities-2026/https://novapharmanews.com/us/news/thma-pharmacy-growth-priorities-2026/The Health Management Academy has released 2026 strategic priorities for Chief Pharmacy Officers, emphasizing workforce resilience, AI governance, and revenue cycle optimization amid policy pressures and evolving market demands.Mon, 04 May 2026 05:02:27 GMTnewsuscardiologyDr. Sarah Mitchell