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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 12 voting members disagreed about how effective the ReCor Paradise system will be in the long run. Read More
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 FDA Commissioner Robert Califf on Tuesday. Read More
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 filed a lawsuit, joining other drugmakers’ and the U.S. Chamber of Commerce’s challenges. Read More
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. Read More
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 are true and a requirement to divest key lines of business. Read More
Ten years and $2.5 billion — that’s what it takes, on average, to bring a new drug to market in the United States. Artificial intelligence (AI) promises to supercharge this process, drastically reducing the time and costs of bringing life-saving therapies to market. Read More
The FDA has issued multiple draft and revised product-specific guidances that provide recommendations on the design of bioequivalence studies to support ANDAs and facilitate generic drug product availability. Read More
After suffering the setback of a complete response letter (CRL) concerning its contract manufacturing plant, Regeneron has bounced back with FDA approval of two drugs — Eylea HD (aflibercept 8 mg) and Veopoz (pozelimab-bbfg). Read More
Krystal Biotech is offloading its priority review voucher (PRV) for a cool $100 million to an undisclosed buyer, a practice that nets companies cash — in highly variable amounts. Read More
The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the sympathetic nerves that wrap around the renal artery. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
A federal appeals court has rejected four provisions of an Oklahoma law regulating prescription benefit managers (PBM), arguing the provisions were preempted by existing federal law. Read More