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A Look Back at FDA News from March 2019


A Look Back at FDA News from March 2019 - Targeted Oncology

A look back at all the FDA news that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, ...

January - March 2019 | Potential Signals of Serious Risks/New ...

January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS).

FDA approves atezolizumab for PD-L1 positive unresectable locally ...

On March 8, 2019, the Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ, Genentech Inc.) in combination with paclitaxel ...

FDA approves atezolizumab for extensive-stage small cell lung cancer

On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and ...

Nondestructive Analytics for Biologics and Continuous ... - FDA

University of Maryland CERSI. Tuesday, March 19, 2019. Presented by: Picture of Brue Yu, Ph.D. Bruce ...

A Look Back at FDA News From March 2023 - Targeted Oncology

Additionally, multiple drugs were granted orphan drug status in March,1 drug was granted breakthrough therapy designation, and 1 drug was ...

FDA approves new nasal spray medication for treatment-resistant ...

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov ...

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy ...

We anticipate that 2019 will be an equally productive year for the FDA's compounding program, with better quality continuing to be our top ...

News Features - Genentech

On March 8, 2019, the FDA granted accelerated approval to a Genentech ... back after surgery or that their healthcare provider decides cannot be ...

FDA approves a new generic valsartan

When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. As ...

CDC Museum COVID-19 Timeline

March 28, 2020 ... To prevent the spread of COVID-19, the White House extends all social distancing measures until through the end of April 2020. FDA issues an ...

FDA approves new generic valsartan to... (CNN News) - NCBI

CNN News March 12, 2019. FDA approves new generic valsartan to make up for drug shortage | CNN. The US Food and Drug Administration approved a new generic ...

Drug News and FDA Alerts - American Epilepsy Society

Ganaxolone (Ztalmy®) – Friday, March 18, 2022 | The FDA approved a new drug application that provides for the use of Ztalmy oral suspension for the treatment of ...

Chronic Lymphocytic Leukemia: FDA Updates

November 21, 2019 – The U.S. Food and Drug Administration (FDA) approved the use of acalabrutinib (CALQUENCE) for the treatment of adult patients with ...

The Best of 2022: FDA Approvals and the Breakthroughs That ...

In the year 2022, as of December 30, the FDA has issued 40 new actions related to cancer care, including 28 regular approvals, nine accelerated ...

U.S. Food and Drug Administration (FDA) | Oncology Nursing Society

December 17, 2019|6 min read. FDA Approves ... NIH: A Look Back at 2017 in Research ... (FDA) commissioner when Scott Gottlieb stepped down in March 2019.

USDA and FDA Announce a Formal Agreement to Regulate Cell ...

WASHINGTON, March 7, 2019 — The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of ...

FDA Approves Atezolizumab for Triple-Negative Breast Cancer - NCI

Accelerated approvals are based on early data from studies which strongly suggest that patients benefit from a treatment. Under accelerated ...

FDA Updates & Press on ARB Recalls: Valsartan, Losartan and ...

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect ...

Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for ...

Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation. March 2019, Vol 12, Tenth Annual Payers' Guide ...