FDA Approval - Search News

Novo Nordisk’s Ozempic Gets FDA Approval

CNN on MSN · 11h

FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients

Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with chronic kidney disease,

Reuters on MSN · 9h

US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression

The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney disease (CKD),

The Wall Street Journal on MSN · 12h

Novo Nordisk’s Ozempic Gets FDA Approval as Kidney-Disease Treatment

Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, Novo Nordisk said.

FDA, breast cancer

The American Journal of Manag… · 18h

FDA Approves Trastuzumab Deruxtecan for HER2-Low/Ultralow Breast Cancer

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

FDA expands Enhertu approval for breast cancer

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of the agent by patients with HER2-low or HER2-utralow metastatic breast cancer whose disease progressed after at least one endocrine therapy.

Business Insider · 1d

FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer

The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU

Medical News Today1d

FDA-approved nasal spray for severe depression can lead to remission

The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in ...

6d

FDA approves first-of-its-kind nasal spray for severe depression

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...

23h

Vertex is hoping for 'historic' non-opioid painkiller approval. It might not be a straightforward blockbuster.

This week, the FDA will decide whether to approve Vertex Pharmaceuticals' non-opioid painkiller. Vertex believes pain could ...

U.S. health agencies see some chaos — but an FDA approval gets through

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FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease

Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...

Managed Healthcare Executive1d

FDA Approves First BTK Inhibitor as First-Line Therapy for Mantle Cell Lymphoma

The drug received accelerated approval in October 2017 as monotherapy for adults with MCL who have received at least one ...

Stereotaxis Magic ablation catheter is now CE mark approved

Stereotaxis said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter.

Hosted on MSN1d

BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug

Biogen BIIB announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered ...

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