The Informed Consent Action Network says FDA should revoke the EUA for Pfizers Covid vaccine in children ages 12-15 and not approve an EUA for Moderna...
FDA cautions Santhigram Kerala Ayurvedic Co. of U.S. that it is marketing unapproved new drugs, including two it says will treat Covid-19.
U.S. PIRG and other advocacy groups urge that stricter enforcement of post-market clinical trials for accelerated approval drugs be included in FDA us...
FDA publishes a draft guidance with questions and answers on developing antibacterial therapies for patients with an unmet medical need to treat serio...
Vanda Pharmaceuticals asks the DC federal court to set aside an FDA determination that the companys tradipitant does not qualify for a fast track desi...
FDA clears a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism.
FDA places a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF) that is designed t...
FDA releases the FDA-483 with six observations from an inspection at Indias Aurobindo Pharma drug manufacturing facility.