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Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval after regulators hinted the Alzheimer’s drug did not have sufficient enough data to support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...
Reports of two patients who found relief from long COVID after taking Pfizer Inc’s (PFE.N) antiviral Paxlovid, including a researcher who tested it on herself, provide intriguing evidence for clinical trials to help those suffering from the debilitating...
Ethnic diversity in clinical trials has been lacking for years. Multiple companies have recognized this lapse and have made changes accordingly, but less has been done on a larger regulatory scale. Now, the U.S. Food and Drug Administration is urging drugmakers to...
The U.S. Food and Drug Administration granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) Breakthrough Therapy Designation. The vaccine is for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia. It is...
The United States on Wednesday renewed the COVID-19 public health emergency, allowing millions of Americans to keep getting free tests, vaccines and treatments for at least three more months. The public health emergency was initially declared in January 2020, when the...
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