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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
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
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. Read More
Amphista Therapeutics has entered into two lucrative partnerships that could potentially net the company more than $2 billion in sales, royalties and performance-based milestone payments. Read More
A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June. Read More