FDA News

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...

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...

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...

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...

GUILFORD, Conn.--(BUSINESS WIRE)--PRIME study results show bedside portable MRI cut order-to-scan time vs conventional MRI and identified critical ED findings....

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...

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...

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...

BOSTON--(BUSINESS WIRE)--Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic (CDx) for TEPMETKO® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. TEPMETKO received accelerated approval from the FDA in February 2021 and traditional approval in Feb...

WEST BRIDGEWATER, Mass.--(BUSINESS WIRE)--Theromics appoints Andrew C. Zeringue as Chief Executive Officer....