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 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 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.