Challenge to US drug price negotiation program revived by appeals court
A U.S. appeals court revived a lawsuit on Friday by healthcare and drug industry groups challenging the first-ever U.S. law ...
STAT2d
FDA’s new head of device safety held senior role at company troubled by safety warnings
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...
With TV Drug Ads, What You See Is Not Necessarily What You Get
The U.S. is one of only two countries that legally allows drugmakers to advertise products directly to patients. There are ...
Silo Pharma Announces Completion of FDA Pre-IND Meeting to Advance Development of SPC-15 for Treatment of PTSD
Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approvalAdvancing path to IND submission for first-in-human trialsSARASOTA, ...
The Floridian4d
Rubio Writes to FDA, Warns of America's Dependence on Foreign Pharmaceuticals
Senator Marco Rubio (R-FL), alongside Senator Angus King (I-ME), sent a letter to Food and Drug Administration (FDA) ...
FTC sues three largest drug middlemen for allegedly inflating insulin prices
The Federal Trade Commission (FTC) on Friday sued the three largest pharmacy benefit managers (PBMs) for engaging in alleged ...
FTC sues drug middlemen over manipulating the insulin market
The agency alleges CVS’s Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx accepted money from drugmakers in ...
KTTV5d
FDA to propose new food label warnings to combat obesity
The FDA is considering food labels to help consumers identify products with unhealthy ingredients, but some experts wonder if ...
Florida Politics10d
FDA kicks the can down the road on citrus grower aid
Florida’s citrus growers watched Tuesday’s Energy and Commerce Subcommittee hearing on Capitol Hill in hopes there would be ...
Vironexis Biotherapeutics Launches with FDA Clearance of IND Application for First-Ever Clinical Trial of an AAV-delivered Cancer Immunotherapy
Vironexis’s off-the-shelf, single-dose gene therapies aim to deliver cancer treatments that are safer, more effective and long-lasting, and more easily manufactured and administeredLeveraging its ...
STAT5d
FDA formalizes protocol for international cancer trials
The FDA issued draft guidance on oncology clinical trials, taking the first steps toward formalizing a position that it's ...
Federal Trade Commission sues largest drug middlemen for allegedly inflating insulin prices
The Federal Trade Commission took action Friday against the three largest pharmacy benefit managers, accusing the companies ...