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Daiichi Sankyo

Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for HER2...

In a statement earlier today, Daiichi Sankyo confirmed that it has submitted a supplemental New Drug Application (sNDA) to...

IND for RemeGen’s Disitamab Vedotin Marks Important Milestone for the Company’s First US-based Clinical...

The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application allowing Yantai (Shandong Province;...

Mersana Reports Updated Data from the XMT-1536 Phase I Dose Escalation Study; Raises U.S....

Mersana Therapeutics, a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers...

Potential Accelerated Approval for Enfortumab Vedotin in Combination with Pembrolizumab as First-Line Treatment for...

Updated data from the phase Ib/II multicohort EV-103 trial (NCT03288545; also known as KEYNOTE-869) of enfortumab vedotin* (Padcev™; Seattle...
Woman Having Chemotherapy With Nurse Using Digital Tablet

COVID19 Expected to Impact Clinical Trials and Slow Down Drug Development

One of the long-term effects of the ongoing COVID19 pandemic is a slowing down of global drug development, leading...

FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin-ejfv in First-Line Advanced Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma and...
The Eye. Image Courtesy: Pete Linforth / Pixabay

Phase Ib Study Shows Safety, Efficacy and Durability of KSI-301

Promising safety, efficacy and durability data from the ongoing Phase Ib study of Kodiak Sciences' investigational therapy KSI-301, in...

Updated Results from Trial Shows Enfortumab Vedotin + Pembrolizumab to Shrink Tumors in the...

Updated findings from EV-103, a phase Ib/II clinical trials of enfortumab vedotin* (Padcev™; Astellas Pharma/Seattle Genetics) in combination with...
Daiichi Sankyo, Basking Ridge, NJ. Courtesy: Daiichi Sankyo.

DESTINY-Gastric01 Trial of Trastuzumab Deruxtecan Versus Chemotherapy Met Primary Endpoint

The pivotal phase II DESTINY-Gastric01 trial (NCT03329690) of known as trastuzumab deruxtecan, previously known as DS-8201, in patients with...

U.S. FDA Grants Orphan Drug Designation for OBI-999 in Gastric Cancer

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to OBI Pharma's OBI-999 for the treatment...