News
🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
Latest News
InflaRx Reports Favorable Safety Profile for Izicopan in Liver Metabolism Study
InflaRx announces positive pre-clinical data showing low reactive metabolite formation for izicopan in human liver microsomes, supporting drug safety profile.
Celcuity's Gedatolisib Meets Phase 3 Primary Endpoint in PIK3CA Mutant Cancer Trial
Celcuity's VIKTORIA-1 Phase 3 trial shows clinically meaningful progression-free survival improvement with gedatolisib in PIK3CA mutant patients.
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Enters Diabetes Market
FDA approves LANGLARA as interchangeable biosimilar to Lantus insulin glargine, marking Lannett Company's entry into diabetes treatment market through Lanexa Biologics.
FDA Approves Guardant360 CDx as Companion Diagnostic for Pfizer's VEPPANU in ER+/HER2- Breast Cancer
Guardant Health receives FDA approval for Guardant360 CDx liquid biopsy test as companion diagnostic for VEPPANU (vepdegestrant) in advanced breast cancer patients.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis and Blood Disorders
Incyte receives FDA approval for once-daily Jakafi XR (ruxolitinib) extended-release tablets for myelofibrosis, polycythemia vera, and GVHD treatment.
Arvinas VEPPANU (Vepdegestrant) Receives FDA Approval as First PROTAC Drug for ESR1-Mutated 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.
Excipient World Conference: Key Highlights and Industry Trends
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.
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.
APHL 2026: Day 1 Highlights and Key Takeaways
APHL 2026 Annual Conference opened with Day 1 sessions focused on diagnostic innovation, infectious disease surveillance, and collaborative strategies for strengthening public health laboratory science across U.S. jurisdictions.
FDA Approves Palazestrant for Breast Cancer Amidst Data Concerns
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.
THMA Pharmacy Growth Priorities 2026: Key Insights for CPOs
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.
CPhI Americas 2026: Pharma Manufacturing Trends in Philadelphia
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.
IPEC Americas Annual Meeting: Key Highlights and Industry Trends
The International Pharmaceutical Excipients Council (IPEC) Annual Meeting 2026 status remains unconfirmed as of publication. NovaPharmaNews was unable to obtain official verification from IPEC regarding whether the pharmaceutical industry event proceeded, was postponed, or was canceled.
Excipient World Conference: Day 1 Highlights
The Excipient World Conference 2026 convened pharmaceutical industry leaders to discuss formulation innovation, regulatory compliance, and supply chain resilience. Day 1 highlighted emerging trends in functional excipients, sustainable sourcing, and opportunities for addressing complex bioavailability challenges.
APHL 2026 Annual: Day 1 Key Takeaways for Public Health Labs
APHL 2026 Annual Conference convened public health laboratory professionals to address infectious disease surveillance, diagnostic innovation, and laboratory operations. While specific Day 1 details await official confirmation, the conference reflects ongoing industry priorities in modernizing diagnostic capabilities and strengthening laboratory infrastructure.
XtalPi-Enabled PEP08 PRMT5 Inhibitor Begins Phase I 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.
Mirum Pharmaceuticals VISTAS Study Results for Volixibat in Primary Sclerosing Cholangitis Due May 4, 2026
Mirum Pharmaceuticals will announce topline results from the VISTAS study of volixibat for primary sclerosing cholangitis treatment on May 4, 2026.
Everads Therapy Publishes First-in-Human Clinical Data for Suprachoroidal Injector in 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.
UCB Acquires Candid Therapeutics in Major Autoimmune Drug Development Deal
UCB's acquisition of Candid Therapeutics strengthens autoimmune pipeline as Two River and Vida Ventures celebrate successful exit from clinical-stage biotech.
Spinogenix Tazbentetol Shows Neuroprotective Effects in Glaucoma and Diabetic Retinopathy Preclinical Studies at ARVO 2026
Spinogenix presents preclinical data showing Tazbentetol (SPG302) reduces retinal cell loss and preserves visual function in eye disease models at ARVO 2026.