Phase 3 IMAgINATION Trial of Sefaxersen Meets Primary Endpoint in IgA Nephropathy

Investigational once-monthly therapy significantly reduced proteinuria versus placebo at 37 weeks, according to interim findings from the phase 3 study. As reported on PharmaBiz, Roche has reported positive interim findings…

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FDA Grants Priority Review to Imfinzi-Enfortumab Vedotin Regimen for Muscle-Invasive Bladder Cancer

As reported on PharmaBiz, the FDA has accepted AstraZeneca’s supplemental Biologics License Application for durvalumab plus neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who cannot receive or have…

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Singapore Approves Wegovy for MASH With Moderate to Advanced Liver Fibrosis

Semaglutide 2.4 mg becomes Singapore’s first approved therapy for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis and F2-F3 fibrosis. As reported on the Manila Times, Singapore’s Health Sciences Authority (HSA) has…

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Organoid Advances Could Open New Paths for Spinal Cord and Peripheral Nerve Repair

As reported on News Medical, researchers are increasingly exploring laboratory-grown organoids as potential tools for repairing damage caused by spinal cord and peripheral nerve injuries. A review published in Engineering…

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FDA Greenlights Acepodia’s Investigational ADC Candidate ACE723 for Advanced Liver Cancer Trial

As reported on PharmaBiz, the US Food and Drug Administration (FDA) has authorized Acepodia to proceed with clinical testing of ACE723, an investigational antibody-drug conjugate (ADC) designed for patients with…

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Roche-Partnered B7-H3 ADC Meets Phase 3 Endpoint in Small Cell Lung Cancer, Shows Competitive Safety Profile

As reported on Fierce BioTech, a phase 3 study conducted by MediLink has delivered positive results for Roche-partnered antibody-drug conjugate (ADC) tambotatug pelitecan (tam-peli), also known as YL201, in patients…

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Imfinzi–Imdelltra Combination Extends Survival in First-Line Extensive-Stage Small Cell Lung Cancer

As reported on PharmaBiz, a combination of Imfinzi (durvalumab) and Imdelltra (tarlatamab) has delivered significant improvements in survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC), according to…

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FDA Authorizes Daraxonrasib for Metastatic Pancreatic Cancer After Positive Phase 3 Trial Results

As reported on World Pharma News, the U.S. Food and Drug Administration has granted approval to daraxonrasib, an oral RAS-targeting therapy, for adults with metastatic pancreatic adenocarcinoma who have previously…

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Guardant360 CDx Approved as Companion Diagnostic for AstraZeneca’s Etcamah in ESR1-Mutated Breast Cancer

As reported on Fierce BioTech, Guardant Health has secured U.S. Food and Drug Administration approval for its Guardant360 CDx liquid biopsy test as the companion diagnostic for AstraZeneca’s newly approved…

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BMS Achieves Milestone with Next-Generation CAR-T Therapy for Multiply-Treated Myeloma Patients

GPRC5D-Targeting Approach Positions Company to Expand Post-BCMA Treatment Options As reported on Fierce BioTech, Bristol Myers Squibb announced positive results from its pivotal Quintessential trial evaluating arlocabtagene autoleucel, a genetically…

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FDA Clears Takeda’s Mimrylo for Polycythemia Vera, Introducing a Novel Treatment Option

As reported on MedCity News, the U.S. Food and Drug Administration has approved Takeda Pharmaceutical’s Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a rare…

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BioNTech Ends Phase 2 Trial of Personalized mRNA Therapy in High-Risk Colorectal Cancer

As reported on Drugs, BioNTech has decided to halt development of its Phase 2 BNT122-01 study investigating autogene cevumeran (BNT122/RO7198457) in patients with resected colorectal cancer who remained ctDNA-positive after…

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Phase 3 HERIZON-GEA-01 Analysis Strengthens Survival Evidence for Zanidatamab-Based Regimens in HER2-Positive Gastroesophageal Cancer

As reported on PharmaBiz, BeOne Medicines has reported positive results from the second interim analysis of the phase 3 HERIZON-GEA-01 trial, further supporting the use of zanidatamab (Ziihera)-containing regimens as…

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FDA Approves PharmaEssentia’s Besremi for Essential Thrombocythaemia

As reported on Pharmaceutical Technology, the US Food and Drug Administration (FDA) has granted approval to PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythaemia (ET), providing…

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