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WALTHAM, Mass. & GENEVA--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in...

SAN CARLOS, Kalifornien--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), ein globales Onkologieunternehmen, hat heute bekannt gegeben, dass die US-amerikanische Food and Drug Administration (FDA) eine neue Tablettenformulierung von BRUKINSA® (Zanubrutinib) für alle fünf zugelassenen Indikationen genehmigt hat. BRUKINSA ist in den USA nach wie vor führend bei den Neueinweisungen von Patienten mit chronischer lymphatischer Leukämie (CLL) über alle Therapielinien hin...

SAN CARLOS, Californie--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ : ONC ; HKEX : 06160 ; SSE : 688235), une société d’oncologie internationale, a annoncé aujourd’hui que la Food and Drug Administration (FDA) des États-Unis avait approuvé une nouvelle formulation sous forme de comprimés de BRUKINSA® (zanubrutinib) pour les cinq indications approuvées. BRUKINSA reste le leader en termes de nombre de démarrages de nouveaux traitements chez les patients atteints de leucémie lymphocytaire chroni...

SAN CARLOS, California--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), empresa internacional de oncología, ha anunciado hoy que la Food and Drug Administration (FDA) de EE.UU. ha aprobado una nueva formulación en comprimidos de BRUKINSA® (zanubrutinib) para las cinco indicaciones aprobadas. BRUKINSA sigue siendo el fármaco líder en el lanzamiento de nuevos tratamientos contra la leucemia linfocítica crónica (LLC) en todas las líneas de tratamiento en los EE.UU. y...

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), azienda globale in ambito oncologico, oggi ha annunciato che la Food and Drug Administration (FDA) statunitense ha approvato una nuova formulazione in compresse di BRUKINSA® (zanubrutinib) per tutte le cinque indicazioni approvate. BRUKINSA rimane il farmaco leader negli avvii di nuovi pazienti affetti da leucemia linfatica cronica (LLC) in tutte le linee terapeutiche negli Stati Uniti e, per la p...

LYON, France--(BUSINESS WIRE)--ENYO Pharma (« ENYO »), société de biotechnologie en phase clinique spécialisée dans le développement d'agonistes FXR pour le traitement des maladies rénales sévères, a annoncé aujourd'hui la poursuite harmonieuse de son essai de phase 2 ALPESTRIA-1 mené auprès de 26 patients atteints du syndrome d'Alport. Les premiers résultats de l'essai sont attendus au quatrième trimestre 2025. Parallèlement, ENYO a finalisé son tour de financement de série C avec un investiss...

LYON, France--(BUSINESS WIRE)--ENYO Pharma (“ENYO”), a clinical-stage biotechnology company focused on developing FXR agonists for the treatment of severe kidney diseases, today announced the smooth continuation of its Phase 2 ALPESTRIA-1 trial in 26 Alport syndrome patients. The topline results from the trial are on track for the fourth quarter of 2025. In parallel, ENYO has finalized its Series C financing round with a €6 million investment from Vesalius Biocapital IV, bringing the total Seri...

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), een wereldwijd oncologiebedrijf, heeft vandaag aangekondigd dat de Amerikaanse Food and Drug Administration (FDA) een nieuwe tabletformulering van BRUKINSA® (zanubrutinib) heeft goedgekeurd voor alle vijf goedgekeurde indicaties. BRUKINSA blijft marktleider in nieuwe patiënten met chronische lymfatische leukemie (CLL) in alle therapielijnen in de VS en is voor het eerst marktleider geworden op het...

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader....

NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). IBTROZI is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address...