TOKYO, Japan and MUNICH, Germany — The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY® (datopotamab deruxtecan) as monotherapy for the first-line 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...
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PHOENIX, Ariz. — It seems everyone is soliciting donations for Nov. 30’s Giving Tuesday, the global generosity movement that falls each year on the Tuesday after Thanksgiving. Created in 2012 as a philanthropic response to consumerism and the buying frenzy of Black Friday and Cyber Monday, Giving Tuesday unleashes the...
CARLSBAD, Calif. — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is the first and only RNA-targeted medicine approved for HAE, designed...
CARLSBAD, Calif. — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of DAWNZERA™ (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12...
Dawson James – Can-Fite (CANF): Two Patients Alive at Four years – Let’s Go Pivotal Can-Fite announced new data from the Phase 2 advanced liver cancer study, including overall survival of nearly four years in two patients who are under namodenoson treatment. We are looking for a stream of regulatory...
BRISBANE, Calif. – Day One Biopharmaceuticals Inc. (Nasdaq: DAWN), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment...
London, England – There are ~7,000 rare diseases that together affect 300 million people. For the vast majority of these patients there are no approved treatments, representing a huge unmet medical need. Advances in the understanding of the molecular basis of rare diseases, the continued development of therapeutic platforms such...
LAUSANNE, Switzerland — Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life, today announced the successful completion of patient enrollment in its open-label, single-arm, multi-center Phase III study (NCT06129539) ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326...
LAUSANNE, Switzerland – Debiopharm (www.debiopharm.com), a Swiss-based global biopharmaceutical company, today announced the signature of an exclusive license agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, for the development and commercialization of xevinapant (Debio 1143). Xevinapant, a potent, oral of Inhibitor of Apoptosis Proteins (IAP) antagonist,...
LAUSANNE, Switzerland — Debiopharm, a privately-owned, Swiss-based biopharmaceutical company committed to establishing tomorrow’s standards of care in oncology and rare diseases, today announced that the first patient has been randomized in the OXTEND-03™ clinical trial. This pivotal Phase III trial is designed to evaluate the efficacy and safety of Debio 4126, a...