FDA issues a complete response letter for Zosano Pharmas Qtrypta 505(b)(2) NDA.
Federal Register notice: FDA makes available a draft guidance entitled Annual Status Report Information and Other Submissions for Postmarketing Requir...
Eli Lilly says it has retained an outside consultant to conduct a comprehensive independent review of systems at its Branchburg, NJ site, following tw...
FDA grants fast track designation for TG Therapeutics ublituximab and umbralisib to treat chronic lymphocytic leukemia.
A Wired investigation details how Quincy Bioscience has made millions from Prevagen sales despite many FDA questions and consumer complaints.
FDA clears a Tyber Medical 501(k) for its new line of foot and ankle plating systems.
FDA asks Helius Medical Technologies for more information to support its request for de novo clearance of its portable neuromodulation stimulator.
The Justice Department announces a global settlement with Purdue Pharma and the Sackler family worth more than $8.3 billion.