The ongoing efforts by the White House to make major dents in drug pricing brought heated criticism from Senate Republicans this week with President Joe Biden’s reported interest in seizing…
The FTC, Department of Justice (DOJ) and HHS have jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over healthcare, further signaling the Biden administration’s commitment…
With stern warnings of potential seizure, injunctions and civil money penalties for failure to comply, the FDA’s warning letter to Fresenius Kabi’s spells out multiple areas in need of corrective…
Dexcom’s Stelo Glucose Biosensor system on Tuesday received the first FDA marketing clearance for an OTC continuous glucose monitor. Source: Drug Industry Daily
On Tuesday, the FDA’s Medical Imaging Drug Advisory Committee (MIDAC) green lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies. Source:…
Digital health technologies are uniquely effective tools for screening, diagnosing, and managing both type 1 and type 2 diabetes, according to stakeholders who commented in response to the FDA’s request…
AI models developed by GE HealthCare used readily available clinical data to forecast cancer immunotherapy outcomes and adverse reactions with 70-80 percent accuracy, according to an article published in the…
The FDA met its March 5 deadline to provide Vanda Pharmaceuticals with the details of its decision to deny the company’s request for a hearing on an sNDA for a…
President Biden announced on Monday that manufacturers for all ten drugs have agreed to participate in the Inflation Reduction Act (IRA) drug price negotiations — but that negotiations continue as…
In a likely boost to Joe Biden’s affection for Delaware, a federal judge in U.S. District Court there Friday handed a victory to the President’s much-challenged Inflation Reduction Act (IRA),…