We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
With the change to regular approval, Enhertu can now be used in earlier lines of treatment in patients with HER2-positive metastatic breast cancer. Read More
Citing the risk of rare blood clots, the FDA announced late yesterday that it is limiting the Emergency Use Authorization (EUA) for the Johnson & Johnson/Janssen COVID-19 vaccine to certain individuals. Read More
The FDA has issued a warning letter to the Age Management Institute (AMI) in Santa Barbara, Calif., for violations that caused its compounded drugs to be adulterated. Read More
Johnson & Johnson (J&J) has sued a New York-based drug cost-saving firm, SaveOnSP, for allegedly overcharging J&J’s financial assistance program meant to help patients pay for expensive prescription drugs. Read More
FDA Commissioner Robert Califf has said the FDA still has a lot of work to do with regard to the pandemic, and in particular, he doesn’t think the agency is doing enough with COVID-19 therapeutics. Read More
One day after Pfizer CEO Albert Bourla said physicians could prescribe a second course of the company’s oral COVID-19 treatment Paxlovid to patients who suffer a rebound, the FDA refuted the executive’s statement. Read More
By rejecting the national settlement, the state gained an extra $46 million to help pay for substance abuse treatments and other strategies to address the opioid crisis, said State Attorney General Bob Ferguson. Read More
Kymriah is considered a gene therapy product where its active ingredient tisagenlecleucel consists of genetically modified white blood cells. Read More
The FDA slapped Dupont Nutrition’s excipient manufacturing facility in Newark, Del., with an eight-observation Form 483 following an inspection in November to December 2021 that revealed inadequate procedures and other quality lapses. Read More