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...
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...
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...
Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and development in immuno-oncology, announced that the company has been granted a patent (Patent No. US 11,299,550 B2) on its anti-CD73 antibodies by the United States Patent and...
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