In Brief: Zimmer's NexGen
This article was originally published in The Gray Sheet
Executive Summary
Zimmer's NexGen: Company launches knee implant system following 510(k) clearance on Jan. 30. According to Zimmer, the system provides surgeons with "greater accuracy and flexibility" and includes patented milling technology to cut and shape bone...You may also be interested in...
Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Horizon's Teprotumumab Breezes Through US FDA Adcom, But Safety Questions Remain
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: