Clinical Trials News

BORDEAUX, France--(BUSINESS WIRE)--TreeFrog Therapeutics, a regenerative medicine biotech company developing next-generation cell therapies, today announced that it will present new preclinical data on TFG-001 at the 7th World Parkinson’s Conference. TFG-001, a 3D neural microtissue cell therapy, demonstrated rapid dopamine release and extensive graft-derived reinnervation across multiple advanced translational Parkinson’s disease models—supporting its potential as a best-in-class candidate. Th...

SAN DIEGO & SEOUL, South Korea--(BUSINESS WIRE)--Inocras, a bioinformatics-led company harnessing the power of whole-genome data and proprietary analytics to deliver curated insights, today announced that new real-world evidence evaluating whole-genome sequencing-based homologous recombination deficiency phenotyping has been accepted for online publication at the 2026 American Society of Clinical Oncology Annual Meeting. The abstract, titled “Whole-genome HRD phenotyping as a predictor of PARP...

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...

AMSTERDAM--(BUSINESS WIRE)--Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat)...

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...

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced five upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2026 Congress. The ASCO annual meeting will be held...

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...

TOKYO--(BUSINESS WIRE)--Enhertu Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that it will host a conference call and webcast on Monday, June 1, 2026 at 8:30 a.m. ET to discuss data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests that will be presented at the 2026 ASCO Annual Meeting. This includes results from the OPTIMA and ENZAMET trials. Professor Iain Macpherson, one of the principal i...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for ad...