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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
AstraZeneca’s blockbuster type 2 diabetes drug Farxiga (dapagliflozin) has already proved its efficacy in treating advanced heart failure. Now, the sodium-glucose cotransporter-2 (SGLT2) Inhibitor is showing promise as a treatment for early heart failure as well. Read More
Medicago’s investigational COVID-19 vaccine, bioengineered in the leaves of a relative of the tobacco plant, was 71 percent effective against any symptomatic cases and 78.8 percent effective against moderate-to-severe COVID-19 disease, researchers have reported. 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