Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and… read more.
The European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) from Sanofi for the treatment of adult patients with relapsed and refractory multiple… read more.
Genmab A/S announced that the FDA has notified Novartis that the agency has extended its review of the supplemental Biologics License Application (sBLA) for subcutaneous ofatumumab for the… read more.
Results from the phase II DESTINY-CRC01 trial of Daiichi Sankyo Company, Limited and AstraZeneca’s Enhurtu (fam-trastuzumab deruxtecan-nxki) demonstrated clinically meaningful activity in patients with HER2 positive unresectable and/or… read more.
Iterum Therapeutics announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 phase III clinical trial in complicated urinary… read more.
Results from the ongoing phase II DESTINYLung01 trial showed Daiichi Sankyo Company, Limited and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) achieved a clinically meaningful tumor response in patients with HER2… read more.
VBL Therapeutics announced the presentation of the positive outcome of pre-planned interim analysis results from the OVAL Phase III pivotal clinical trial of VB III in platinum-resistant ovarian… read more.
AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD),… read more.
Gilead Sciences, Inc. announced topline results from the Phase iII SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of… read more.
Eli Lilly and Company announced the FDA has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial… read more.
AVEO Oncology announced that the FDA accepted for filing its New Drug Application (NDA) seeking approval for Fotivda (tivozanib), the Company’s next-generation vascular endothelial growth factor receptor tyrosine… read more.
BioMarin Pharmaceutical Inc. announced an update to its previously reported results of an open-label Phase 1/II study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with… read more.
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