Ardelyx announced the U.S. Food and Drug Administration’s Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), provided an interim response to the company’s second level of appeal for tenapanor. The OND indicated that more input from...
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval after regulators hinted the Alzheimer’s drug did not have sufficient enough data to support potential approval. The Boston-based company disclosed the result of a meeting with the...
As advanced AI models continue to transform our abilities to collect, manage, and expedite health data analysis, applying this innovative technology to address health inequalities is emerging as an important focus for patient-centered care and an important application...
Servier is poised to go to market with a new indication after the Phase III trial of a trial of its leukemia drug in IDH1-mutated acute myeloid leukemia (AML) closed with positive results. The global Agile trial ended with Tibsovo (ivosidenib tablets) in combination...
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers. Dysregulated PI3K signaling helps malignant lymphocytes...
Amid government crackdowns on pharmaceutical companies and increasingly strict federal guidelines, two companies received positive feedback today on their treatments for depression and Vascular Ehlers-Danlos Syndrome (VEDS). The FDA proposed some postmarketing...
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