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Datopotamab, breast cancer and FDA
US FDA approves AstraZeneca's drug for breast cancer
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of breast cancer, the health regulator said on Friday. The treatment, jointly developed with the Japanese company,
FDA Approves Datopotamab Deruxtecan for HR-Positive/HER2-Negative Metastatic Breast Cancer
The approval is based on findings from the phase 3, multicenter, open-label, randomized TROPION-Breast01 trial.
FDA Approves Dato-DXd in HR+/HER2– Breast Cancer
As supported by data from the phase 3 TROPION-Breast01 trial, datopotamab deruxtecan is now an FDA-approved treatment for patients with HR-positive, HER2-negative breast cancer.
AstraZeneca’s Datroway approved in U.S. for HER2-negative breast cancer patients
DXd, has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
AstraZeneca Gets FDA Approval for Metastatic Breast Cancer Treatment Datroway
AstraZeneca said the U.S. Food and Drug Administration approved Datroway, a treatment for metastatic breast cancer developed in combination with Daiichi Sankyo. The Anglo-Swedish drugmaker on Friday said that the approval is for adult breast cancer patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
FDA 'Closely Monitoring' ZYN Nicotine Pouches
FDA approves 20 ZYN nicotine pouches after thorough' safety review
The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a thorough review." These nicotine
Zyn nicotine pouches get FDA approval
FDA authorizes Zyn nicotine pouches, citing public health benefits for adult smokers, despite concerns over flavored products' appeal to teens.
FDA 'Closely Monitoring' Zyn Nicotine Pouches After Marketing Approval
The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but will be "closely monitoring youth use." Newsweek reached out to Zyn for comment.
Healio
19h
FDA approves therapies for colorectal cancer, mantle cell lymphoma
The FDA approved two oncology regimens on Jan. 16.One is for a subset of patients with colorectal cancer and the other for ...
The American Journal of Managed Care
21h
FDA Grants 2 Traditional Approvals for Acalabrutinib
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
15h
Weight loss drug approved to treat sleep apnea
Sleep expert Dr. Abhay Sharma talks about how Zepbound is now approved by the FDA for the treatment of moderate to severe ...
Targeted Oncology
19h
FDA Approves FoundationOne CDx as Companion Diagnostic for Tovorafenib in Pediatric Low-Grade Glioma
FoundationOne CDx is now FDA-approved as the first companion diagnostic for tovorafenib, enabling targeted treatment for ...
2d
on MSN
Eli Lilly Receives FDA Approval for Crohn’s Disease Treatment
Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely-active Crohn’s ...
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