FDA’s Cancer Advisory Committee to Evaluate Safety of PI3K inhibitors
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...
Axsome and Aytu’s Positive Day with the FDA
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...
The case for testing Pfizer’s Paxlovid for treating long COVID
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 condition,...
FDA Issues New Guidance to Increase Minority Representation in Clinical Trials
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...
Merck’s Pneumococcal Vaccine Claims FDA Breakthrough Therapy Designation
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...
U.S. renews COVID-19 public health emergency
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...