FDA-regulated pharmaceutical news, drug approvals, and clinical trial updates for the US and Americas market.https://novapharmanews.com/en-USMon, 04 May 2026 22:25:09 GMThttps://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 GMTnewsHematology/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 GMTnewsJames 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 GMTnewsJames 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 GMTnewsDr. 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 GMTnewsDr. 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 GMTnewsgeneralDr. 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 GMTnewsPancreatic 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 GMTnewsDr. 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 GMTnewsDr. 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 GMTnewsDr. 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 GMTnewsDr. 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 GMTnewsMichael 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 GMTnewsOncologyDr. 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 GMTnewsDiabetes/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 GMTnewsMichael 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 GMTnewsHematology/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 GMTnewsOncology - 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 GMTnewsgeneralDr. 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 GMTnewsgeneralDr. 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 GMTnewsgeneralDr. Sarah Mitchellhttps://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 GMTnewsbreast cancerDr. Natalie Hugheshttps://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 GMTnewscardiologyDr. Sarah Mitchellhttps://novapharmanews.com/us/news/cphi-americas-2026-pharma-manufacturing-trends/https://novapharmanews.com/us/news/cphi-americas-2026-pharma-manufacturing-trends/CPhI Americas 2026 returns to Philadelphia, focusing on pharmaceutical manufacturing trends, contract manufacturing, AI integration, and regulatory shifts. The event is a key meeting point for industry professionals to discuss the evolving landscape.Mon, 04 May 2026 05:00:41 GMTnewsmanufacturingDr. Sarah Mitchellhttps://novapharmanews.com/us/news/ipec-americas-annual-meeting-daily-roundup/https://novapharmanews.com/us/news/ipec-americas-annual-meeting-daily-roundup/The IPEC Annual Meeting 2026 pharmaceutical event status remains unconfirmed by official sources. Pharma professionals should monitor the International Pharmaceutical Excipients Council for updates on this critical industry conference addressing excipient innovation, regulatory compliance, and supply chain resilience.Mon, 04 May 2026 04:02:03 GMTnewsgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/excipient-world-conference-day-1-highlights/https://novapharmanews.com/us/news/excipient-world-conference-day-1-highlights/The Excipient World Conference 2026 opened with industry-wide focus on pharmaceutical excipient innovations, regulatory compliance, and supply chain collaboration. Day 1 featured presentations on advanced drug delivery systems, stability enhancement technologies, and evolving global standards for excipient qualification.Mon, 04 May 2026 04:01:18 GMTnewsgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/aphl-2026-annual-day-1-roundup/https://novapharmanews.com/us/news/aphl-2026-annual-day-1-roundup/Day 1 of the APHL 2026 Annual Meeting highlighted advancements in public health laboratory science and the importance of collaboration, covering topics from infectious disease control to laboratory technology innovations. Networking events fostered discussions and partnerships to tackle public health challenges.Mon, 04 May 2026 04:00:32 GMTnewsgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/xtalpi-pep08-prmt5-inhibitor-phase-1-cancer-trial-enrollment/https://novapharmanews.com/us/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 enrollment, marking a key milestone in synthetic lethality cancer treatment.Mon, 04 May 2026 03:02:18 GMTnewsDr. Sarah Mitchellhttps://novapharmanews.com/us/news/mirum-pharmaceuticals-vistas-volixibat-primary-sclerosing-cholangitis-results-may-2026/https://novapharmanews.com/us/news/mirum-pharmaceuticals-vistas-volixibat-primary-sclerosing-cholangitis-results-may-2026/Mirum Pharmaceuticals will announce topline results from the VISTAS study of volixibat for primary sclerosing cholangitis treatment on May 4, 2026.Mon, 04 May 2026 03:01:56 GMTnewsDr. Emily Carterhttps://novapharmanews.com/us/news/everads-therapy-suprachoroidal-injector-clinical-data-ophthalmology-science/https://novapharmanews.com/us/news/everads-therapy-suprachoroidal-injector-clinical-data-ophthalmology-science/Everads Therapy reports favorable safety and tolerability data for its novel suprachoroidal drug delivery device in first-in-human trial published in peer-reviewed journal.Mon, 04 May 2026 03:01:31 GMTnewsDr. Sarah Mitchellhttps://novapharmanews.com/us/news/ucb-acquires-candid-therapeutics-autoimmune-deal/https://novapharmanews.com/us/news/ucb-acquires-candid-therapeutics-autoimmune-deal/UCB's acquisition of Candid Therapeutics strengthens autoimmune pipeline as Two River and Vida Ventures celebrate successful exit from clinical-stage biotech.Mon, 04 May 2026 03:01:05 GMTnewsDaniel Brookshttps://novapharmanews.com/us/news/spinogenix-tazbentetol-neuroprotective-glaucoma-diabetic-retinopathy-arvo-2026/https://novapharmanews.com/us/news/spinogenix-tazbentetol-neuroprotective-glaucoma-diabetic-retinopathy-arvo-2026/Spinogenix presents preclinical data showing Tazbentetol (SPG302) reduces retinal cell loss and preserves visual function in eye disease models at ARVO 2026.Mon, 04 May 2026 03:00:41 GMTnewsDr. Natalie Hugheshttps://novapharmanews.com/us/news/niktimvo-axatilimab-approved-australia-chronic-gvhd-treatment/https://novapharmanews.com/us/news/niktimvo-axatilimab-approved-australia-chronic-gvhd-treatment/Australia's TGA approves NIKTIMVO (axatilimab), a breakthrough first-in-class therapy for chronic graft-versus-host disease under priority review.Mon, 04 May 2026 03:00:20 GMTnewsDaniel Brookshttps://novapharmanews.com/us/articles/fda-approval-pfizer-arvinas-breast-cancer-drug-vepdegestrant/https://novapharmanews.com/us/articles/fda-approval-pfizer-arvinas-breast-cancer-drug-vepdegestrant/The FDA has granted approval for Pfizer and Arvinas' novel breast cancer drug, vepdegestrant. This marks a significant new treatment option for patients with advanced or metastatic HR-positive, HER2-negative breast cancer who have exhausted prior endocrine therapies.Mon, 04 May 2026 01:03:52 GMTanalysisadvanced or metastatic HR-positive, HER2-negative breast cancerKenji Watanabehttps://novapharmanews.com/us/news/ipec-annual-meeting-2026-no-pharma-news/https://novapharmanews.com/us/news/ipec-annual-meeting-2026-no-pharma-news/No official confirmation or breaking pharmaceutical news from the IPEC Annual Meeting 2026 is currently available in public sources. Pharmaceutical professionals should verify event status directly with the International Pharmaceutical Excipients Council.Mon, 04 May 2026 00:04:53 GMTnewsgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/excipient-world-conference-2026-daily-roundup/https://novapharmanews.com/us/news/excipient-world-conference-2026-daily-roundup/The Excipient World Conference 2026 has not generated breaking pharmaceutical news as of May 4, 2026. However, emerging market trends in lipid-based vitamin C, natural oil excipients, and biodegradable packaging solutions provide strategic insights for pharma excipient professionals.Mon, 04 May 2026 00:02:59 GMTnewsgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/aphl-2026-annual-meeting-opens-public-health-lab-focus/https://novapharmanews.com/us/news/aphl-2026-annual-meeting-opens-public-health-lab-focus/The APHL 2026 Annual Meeting commenced today in Baltimore, MD, bringing together public health laboratory leaders, scientists, and partners to discuss critical issues and advancements in the field. The conference, running from May 4–7, will address key trends in laboratory science and public health.Mon, 04 May 2026 00:00:53 GMTnewsgeneralDr. Sarah Mitchellhttps://novapharmanews.com/us/news/axsome-fda-approval-alzheimers-agitation/https://novapharmanews.com/us/news/axsome-fda-approval-alzheimers-agitation/Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.Sun, 03 May 2026 07:03:11 GMTnewsagitation associated with Alzheimer's diseaseDr. Priya Nandakumarhttps://novapharmanews.com/us/news/fda-approves-first-non-antipsychotic-dementia-agitation/https://novapharmanews.com/us/news/fda-approves-first-non-antipsychotic-dementia-agitation/The FDA has approved the first non-antipsychotic medication for agitation linked to dementia from Alzheimer's disease. This landmark approval provides a much-needed alternative to antipsychotics, which carry significant risks for this patient population.Sun, 03 May 2026 07:03:10 GMTnewsagitation associated with dementia due to Alzheimer's diseaseDr. Grace Tanhttps://novapharmanews.com/us/news/edwards-lifesciences-resilia-tissue-10-year-durability-aortic-valve-trial/https://novapharmanews.com/us/news/edwards-lifesciences-resilia-tissue-10-year-durability-aortic-valve-trial/Edwards Lifesciences announces 10-year COMMENCE trial results demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.Sun, 03 May 2026 03:02:02 GMTnewsDr. Priya Nandakumarhttps://novapharmanews.com/us/news/biomarin-voxzogo-achondroplasia-long-term-data-pes-2026/https://novapharmanews.com/us/news/biomarin-voxzogo-achondroplasia-long-term-data-pes-2026/BioMarin presents new VOXZOGO data showing long-term benefits on arm span, bone health and growth in children with achondroplasia at PES 2026 meeting.Sun, 03 May 2026 03:01:25 GMTnewsDr. Emily Carterhttps://novapharmanews.com/us/news/fda-approves-incyte-jakafi-xr-extended-release-myelofibrosis-polycythemia-vera/https://novapharmanews.com/us/news/fda-approves-incyte-jakafi-xr-extended-release-myelofibrosis-polycythemia-vera/Incyte receives FDA approval for Jakafi XR (ruxolitinib) extended-release tablets, offering improved dosing convenience for rare blood cancer patients.Sun, 03 May 2026 03:00:36 GMTnewsHematology/OncologyDaniel Brookshttps://novapharmanews.com/us/articles/auvelity-fda-approval-mdd-treatment/https://novapharmanews.com/us/articles/auvelity-fda-approval-mdd-treatment/The FDA has approved Auvelity, a new oral treatment for major depressive disorder (MDD) in adults, marking a significant advancement in mental health therapeutics. Manufactured by Axsome Therapeutics, this approval offers a novel option for patients seeking relief from MDD.Sun, 03 May 2026 01:03:39 GMTanalysisMajor Depressive Disorder (MDD)Dr. Hannah O'Connorhttps://novapharmanews.com/us/articles/fda-scrutiny-post-market-data-pharma-investment-2024/https://novapharmanews.com/us/articles/fda-scrutiny-post-market-data-pharma-investment-2024/This article examines the implications of FDA scrutiny on post-market data and its influence on pharmaceutical investment strategies and drug development.Sat, 02 May 2026 16:35:37 GMTanalysisDr. Yuna Parkhttps://novapharmanews.com/us/articles/fda-inflation-reduction-act-pharmaceutical-pricing-2026/https://novapharmanews.com/us/articles/fda-inflation-reduction-act-pharmaceutical-pricing-2026/Learn about the Inflation Reduction Act's effects on pharmaceutical pricing, focusing on key medications like insulin and cancer therapies for Medicare patients.Sat, 02 May 2026 16:35:12 GMTanalysisArjun Menonhttps://novapharmanews.com/us/articles/cofepris-approval-trends-2026-mexico-pharma-market/https://novapharmanews.com/us/articles/cofepris-approval-trends-2026-mexico-pharma-market/Explore the implications of COFEPRIS drug approvals in 2026, highlighting regulatory changes and their impact on the market for key medications like XYZ for diabetes.Sat, 02 May 2026 16:34:34 GMTanalysisDr. Priya Nandakumarhttps://novapharmanews.com/us/articles/anvisa-clinical-trial-changes-brazil-2024/https://novapharmanews.com/us/articles/anvisa-clinical-trial-changes-brazil-2024/Learn about the recent changes to ANVISA's clinical trial regulations in Brazil and how they impact drug development for various medical indications.Sat, 02 May 2026 16:34:24 GMTanalysisOncologyInfectious DiseasesJames Chen, PharmDhttps://novapharmanews.com/us/articles/anvisa-regulatory-changes-foreign-drug-manufacturers-market-access-2024/https://novapharmanews.com/us/articles/anvisa-regulatory-changes-foreign-drug-manufacturers-market-access-2024/ANVISA's recent regulatory changes significantly affect foreign drug manufacturers in Brazil, influencing drug approvals and market strategies for key treatments.Sat, 02 May 2026 16:34:11 GMTanalysisDr. Amina Faroukhttps://novapharmanews.com/us/articles/sfda-expedited-review-oncology-drug-approvals-2024/https://novapharmanews.com/us/articles/sfda-expedited-review-oncology-drug-approvals-2024/Learn about the SFDA's expedited review for oncology drugs, including [Drug Name], designed to fast-track approvals and improve patient access to essential cancer therapies.Sat, 02 May 2026 16:33:58 GMTanalysisOncologyDaniel Brookshttps://novapharmanews.com/us/articles/sahpra-accelerated-approval-oncology-2024/https://novapharmanews.com/us/articles/sahpra-accelerated-approval-oncology-2024/Learn how SAHPRA's Accelerated Approval is transforming oncology access, expediting vital treatments like Pembrolizumab for cancer patients in need.Sat, 02 May 2026 16:33:45 GMTanalysisOncologyOliver Granthttps://novapharmanews.com/us/articles/ama-harmonizing-clinical-trials-impact-2024/https://novapharmanews.com/us/articles/ama-harmonizing-clinical-trials-impact-2024/The African Medicines Agency is transforming clinical trials in Africa, streamlining processes for drug approvals and improving access to essential medicines.Sat, 02 May 2026 16:33:32 GMTanalysisHIVMalariaArjun Menon