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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EU Approves Enhertu Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

As reported on Business Wire, the European Commission has approved trastuzumab deruxtecan (Enhertu) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.…

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Roivant and Priovant Secure FDA Approval for First Targeted Oral Therapy for Dermatomyositis

As reported on Pharma Phorum, Roivant Sciences and its subsidiary Priovant Therapeutics have received U.S. Food and Drug Administration (FDA) approval for Lisraya (brepocitinib), marking the first targeted treatment specifically…

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AstraZeneca Secures Global Rights to EGFR-Targeted Lung Cancer Therapy ZEGFROVY

As reported on Business Wire, AstraZeneca has finalized its previously announced licensing agreement with Dizal Pharmaceutical, gaining exclusive worldwide rights to develop and market ZEGFROVY (sunvozertinib), an oral, irreversible epidermal…

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Basking Biosciences formulates Reversable Clot Busting Therapy for Acute Stroke

Treating acute ischemic strokes involves a precarious clinical balance: physicians must dissolve arterial clots to save brain tissue without triggering catastrophic intracranial hemorrhaging. To address the severe bleeding risks associated…

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Lorelei, the SYNGAP1 Warrior

Editor's Note: Patient Worthy is honored to share the following article, originally published by our friends at CURE SYNGAP1. To see the article in its original format, please click here.…

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Orsini Selected as Specialty Pharmacy Partner for Newly Approved Dermatomyositis Therapy LISRAYA

As reported on PR NewsWire, Orsini has been named a specialty pharmacy partner for Priovant’s LISRAYA™ (brepocitinib), a once-daily oral treatment recently approved by the US Food and Drug Administration…

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CARDIO-TTRansform: Eplontersen Fails to Improve Cardiovascular Outcomes When Added to Standard Therapy in ATTR-CM

As reported on Healio, the phase 3 CARDIO-TTRansform study, the largest clinical trial conducted to date in patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM), found that adding eplontersen to contemporary…

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FDA Announces Nationwide Recall of Certain Thyroid Medication Due to Excess Potency Risk

As reported on The Hill, Vitruvias Therapeutics has initiated a voluntary nationwide recall of a specific lot of thyroid medication after testing indicated the tablets may contain higher-than-labeled potency, according…

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Vera’s Trutakna Shows Signs of Preserving Kidney Function in IgA Nephropathy, Challenging Voyxact’s Differentiation

As reported on BioSpace, Vera Therapeutics’ newly approved IgA nephropathy (IgAN) treatment, Trutakna, is showing early evidence that it may help preserve kidney function, a benefit that had recently drawn…

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