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FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotrans...
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Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. This milestone represents yet another example of Galderma’s unique Integrated Dermatology stra...
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DATROWAY® (datopotamab deruxtecan-dlnk) approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
WILMINGTON, Del.--(BUSINESS WIRE)--May 22, 2026 — AstraZeneca and Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Societ...
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Datroway® Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates
TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/NYSE: AZN) Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sank...
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Hyperfine Announces Presentation of Results from the PRIME Study Showing Portable MRI Substantially Reduces Time to Imaging in Emergency Departments
GUILFORD, Conn.--(BUSINESS WIRE)--PRIME study results show bedside portable MRI cut order-to-scan time vs conventional MRI and identified critical ED findings....
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Gilead Receives CHMP Positive Opinion for Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer for Patients Not Candidates for PD-(L)1 Inhibitors
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for met...
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Flatiron Health Brings 25+ Research Acceptances and Next-Generation Capabilities to ASCO 2026
NEW YORK--(BUSINESS WIRE)--Flatiron Health today announced its presence at the American Society of Clinical Oncology (ASCO) Annual Meeting happening from May 29 - June 2, 2026, in Chicago, Illinois. Flatiron's high-quality real-world data and innovative research capabilities are featured across 25+ research acceptances, including 14 Flatiron-authored poster presentations and online publications. Flatiron’s presence at ASCO 2026 closely follows the launch of Flatiron Telescope, a multi-agent ada...
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Artera Presents Multiple ASCO 2026 Abstracts on Multimodal AI (MMAI) Risk Stratification and Treatment Decisions in Cancer
SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, will present multiple abstracts at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, May 29–June 2, 2026, in Chicago. Two breast cancer abstracts demonstrate the performance of Artera’s MMAI across clinically challenging settings. One study assesses prognosis and chemotherapy benefit stratification in node‑positive HR+ breast cancer...
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HAYA Therapeutics annonce l’administration du traitement à la première cohorte dans le cadre de l’essai clinique de phase 1 sur HTX-001, un traitement expérimental de précision visant la reprogrammation cellulaire destiné à la fibrose cardiaque
LAUSANNE, Suisse et SAN DIEGO--(BUSINESS WIRE)--HAYA Therapeutics SA, une société de biotechnologie de précision de stade clinique qui développe des thérapies innovantes, programmables et guidées par l’ARN ciblant le génome régulateur afin de reprogrammer les états cellulaires pathologiques dans les maladies courantes, chroniques et liées à l’âge, a annoncé que la première cohorte avait été recrutée et avait reçu une première administration dans le cadre de l’essai clinique de phase 1 mené par...
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HAYA Therapeutics gibt Dosierung der ersten Kohorte in Phase-1-Studie zu HTX-001 bekannt, einem Prüfpräparat zur gezielten zellulären Reprogrammierung bei Herzfibrose
LAUSANNE, Schweiz, und SAN DIEGO, Kalifornien, USA--(BUSINESS WIRE)--HAYA Therapeutics SA, ein klinisches Biotech-Unternehmen und Wegbereiter im Bereich präzisionsmedizinischer RNA-geführter Therapeutika, gab heute bekannt, dass die erste Kohorte in der klinischen Phase-1-Studie des Unternehmens zur Untersuchung von HTX-001 vollständig aufgenommen und dosiert wurde. Die Therapeutika von HAYA zielen auf das regulatorische Genom ab, um krankheitsfördernde Zellzustände bei häufigen, chronischen un...