The FDA granted AstraZeneca a Priority Review for its blockbuster oncology drug, Imfinzi (durvalumab), combined with chemotherapy, for treatment of patients with locally advanced or metastatic biliary tract cancer (BTC),…
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. Source:…
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…
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. Source: Drug Industry…
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…
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…
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…
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 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…
The FDA issued a warning letter to a contract testing laboratory at Miami University in Oxford, Ohio, for significant deviations from current good manufacturing practice (cGMP), including falsified data. Source:…