Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance…
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the…
In a brief filed Monday, Amgen and Horizon argue that the U.S. District Court of Northern Illinois shouldn’t let the Federal Trade Commission (FTC) block their union over concerns that…
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on…
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and webinars…
An FDA advisory panel has endorsed ReCor Medical’s novel ultrasound renal denervation system, agreeing unanimously that it’s safe for use in adults with uncontrolled or inadequately controlled hypertension, although the…
Should the FDA get the 11 percent increase in funding that it’s gunning for from Congress, a large chunk will be spent improving internal data quality at the agency, said…
The legal fight around the Inflation Reduction Act’s (IRA) drug price negotiation policy continues as the AARP and Public Citizen have submitted amicus briefs supporting the law and Boehringer Ingelheim…
Philips has issued an urgent field safety notice for certain of its imaging systems for a potentially faulty foot switch that may lead to unintended radiation. Source: Drug Industry Daily
The Department of Justice (DOJ) has resolved criminal antitrust charges against Teva Pharmaceuticals and Glenmark Pharmaceuticals for price fixing with deferred prosecution agreements, hefty fines, admission that the DOJ’s facts…