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A Los Angeles doctor is the first individual investigator to receive an FDA warning letter for failing to report trial results to ClinicalTrials.gov, a violation that could result in thousands of dollars in fines, the letter said. Read More
Bausch Health has agreed to pay $300 million in cash to settle an antitrust class action on behalf of consumers over the type 2 diabetes drug Glumetza. Read More
Two moderate Democrats in the House are slated to release a rival Democratic drug pricing bill as the party prepares a sweeping $3.5 trillion spending bill that is expected to include legislation aimed at reducing the cost of prescription drugs, especially for seniors. Read More
The guidance clarifies that the FDA will generally accept requests to receive an ANDA without all the recommended stability data if the drug product is on the FDA’s Drug Shortage List. Read More
The FDA has declined to grant Humanigen an emergency use authorization (EUA) for its antibody lenzilumab for treatment of hospitalized COVID-19 patients. Read More
A new lawsuit filed against the FDA this week contends that the male pattern baldness drug Propecia (1 mg) should either be taken off the market or its prescribing information should include warnings about the risk of long-term erectile dysfunction, depression and suicide. Read More
An estimated 8,000 UK citizens suffering from hormone-sensitive or hormone-relapsed prostate cancer will now be eligible to receive treatment. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) rolled out Eli Lilly CEO David Ricks and other prominent drug company executives yesterday to lobby against Congressional efforts to cut drug costs by allowing Medicare to negotiate prices. Read More
The U.S. Court of Appeals for the Federal Circuit has upheld a prior victory for Bristol Myers Squibb and Pfizer covering two Eliquis (apixaban) patents, positioning the companies to keep exclusivity in the U.S. for the blockbuster oral anticoagulant until April 1, 2028. Read More
The FDA has revised its guidance on generic drug development and application submission during the COVID-19 public health emergency, providing additional information and clarification of existing policies but no policy changes. Read More