FDA denies a 2006 citizen petition from UCB that sought labeling on all anti-epileptic drugs warning about drug switching patients who are seizure fre...
A New York Times article examines FDAs alleged foot-dragging over the last decade that allowed e-cigarette use to explode to the detriment of teenager...
FDA extends the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension) that s...
A new JAMA study finds minimal effects from FDAs recent policies to expand approvals for generic drugs at risk for price spikes and shortages.
FDA accepts for review an Ultragenyx Pharmaceutical NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders.
FDA clears an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory devices designed to sup...
A public interest group says FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that led to the recall of...
FDA clears a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air.