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Showing 13–24 of 89 stories
What Does the Teva Settlement Mean for Mayne Pharma (ASX:MYX)? - Kalkine Media
Mayne Pharma has settled US patent litigation with Teva over IMVEXXY, setting a future generic entry date. What the settlement means.
Ultomiris Wins Accelerated FDA Approval for IgA Nephropathy After Trial Showed 43% Greater Drop in Urine Protein
FDA granted Ultomiris accelerated approval for IgA nephropathy based on lower urine protein. What it means and the infection risks to know.
GSK's hepatitis B drug, Hibsago receives US FDA approval
GSK plc announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB)…
Korea to Allow Sale of Drugs Made Before Approval
Korea's drug safety ministry will let drugmakers sell medicines made before product approval if GMP and other requirements are met, part of six…
LTR Pharma Hosts 2026 AGM in Brisbane Highlighting FY26 Achievements and US Market Expansion - Kalkine Media
Small Cell Lung Cancer Pipeline Analysis 2026: Phase III and Phase II Assets, MOA Breakdown, and Route of…
Chronic Spontaneous Urticaria Clinical Trials Update 2026: Phase-Wise Pipeline Status, Drug Profiles, and Key…
Saluda Medical Reports 28% Revenue Surge to $90.2 Million in FY26, Highlights FDA Approval and Leadership Change -…
Armando Rubio, Vicapsys CEO, on Pharmaceutical Supply Chain Resilience, U.S. Manufacturing and Expanding Acces...
As pharmaceutical supply chains become an increasingly important economic and national security priority, Vicapsys Life Sciences, Inc. is pursuing a…
FDA Approval Of First Potential Hep B Cure Comes Amid Heated Vaccine Debate
Body: FDA’s approval this week of the first functional cure for hepatitis B was celebrated by the Hepatitis B Foundation as a significant step…
FDA flags more Olympus safety problems in import block and warning letter
The FDA import alert broadens the scope of a 2025 import action covering dozens of endoscopes and comes two weeks after a new warning letter…
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