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Better Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates - Vimarsana News

Better Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

Advanced preparations for potential commercial launch of BT-001 in U.S. in mid-2023 Reported positive topline results from exploratory trial for fatty liver disease Announced restructuring and... | March 30, 2023

FDA Issues Draft Guidance on "External Controls" in Clinical Trials to Support Safety and Efficacy of a Drug | King & Spalding - Vimarsana News

FDA Issues Draft Guidance on "External Controls" in Clinical Trials to Support Safety and Efficacy of a Drug | King & Spalding

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the...

Mitsubishi Tanabe Pharma America Announces Real-World Data Analysis of Survival with RADICAVA® (edaravone) - Vimarsana News

Mitsubishi Tanabe Pharma America Announces Real-World Data Analysis of Survival with RADICAVA® (edaravone)

/PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of a paper entitled, "Intravenous edaravone treatment in ALS and...

Pfizer Announces Overall Survival Results from Phase 3 PALOMA-2 Trial of IBRANCE® (palbociclib) for the First-Line Treatment of ER+, HER2- Metastatic Breast Cancer - Vimarsana News

Pfizer Announces Overall Survival Results from Phase 3 PALOMA-2 Trial of IBRANCE® (palbociclib) for the First-Line Treatment of ER+, HER2- Metastatic Breast Cancer

Pfizer Inc. today announced overall survival results from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE® in combination with letrozole compared to placebo plus letrozole for the... | June 4, 2022

4 Pitfalls To Avoid With RWE For Regulatory Submissions - Vimarsana News

4 Pitfalls To Avoid With RWE For Regulatory Submissions

Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA...