Federal Register notice: FDA announces a 5/11 public workshop entitled FY 2023 Generic Drug Science and Research Initiatives Workshop.
FDA accepts for filing a Sandoz BLA for a biosimilar version of Amgens denosumab (Prolia and Xgeva), which includes all indications for the reference ...
Medical device manufacturer Joint Active Systems (Effingham, IL) agrees to pay $500,000 under a Justice Department settlement over False Claims Act vi...
FDA approves a Gilead Sciences supplemental BLA for Trodelvy for treating certain adult patients breast cancer who have received endocrine-based thera...
Senator Jeanne Shaheen (D-NH) leads a group of Senators in sending a letter to Danco Laboratories, a manufacturer of mifepristone, urging it to submit...
Federal Register notice: FDA corrects an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple applicants.
Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change on preclinical animal testing may not be as monume...
FDA places a clinical hold on 4D Molecular Therapeutics 4D-310 drug therapy being studied for treating Fabry Disease Cardiomyopathy after the company ...
