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Apogee Therapeutics Expands Board of Directors with the Appointment of Lisa Bollinger, MD

Apogee Therapeutics Expands Board of Directors with the Appointment of Lisa Bollinger, MD
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California
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Dan-budwick
Michael-henderson
Mark-mckenna
Lisa-bollinger
United-states-public-health-service
National-health-service-corp
University-of-california
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Nasdaq

FDA Roundup: May 21, 2024

FDA Roundup: May 21, 2024
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Kevin-bugin
Oncology-center
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Radiological-health
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Equity-program
Online-controlled-substances-summit

FDA Roundup: May 03, 2024

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the...

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FDA's Richard Pazdur explains confirmatory trial rejection, more

FDA's Richard Pazdur explains confirmatory trial rejection, more
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Omeros Corporation (NASDAQ:OMER) Q4 2023 Earnings Call Transcript

Operator: Good afternoon and welcome to today's conference call from Omeros Corporation. At this time, all participants are in a listen-only mode.

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Steve-brozak
Catherine-melfi

Akebia's CKD Anemia Drug Ends Tough Regulatory Path with FDA Approval

After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.

Washington
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John-butler
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Resume
Areers

Reducing The Number Of Clinical Holds On Cell And Gene Therapies Approaches For Sponsors And The FDA

Reducing The Number Of Clinical Holds On Cell And Gene Therapies Approaches For Sponsors And The FDA
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Brenda-sandburg
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Sean-hilscher
Peter-marks
Sandra-kweder
Gene-therapies-advisory-committee
Office-of-therapeutic-products
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Georgetown-university
Beam-therapeutics-inc
Methods-clinical-development

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