MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial ...
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. have landed in the FDA’s crosshairs thanks to quality shortfalls, poor testing standards ...
Shares of Cipla declined 4% on January 7 after the US Food and Drug Administration (FDA) disclosed inspection observations ...
A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the FDA’s crosshairs for the second time in less than a year. The FDA has ...
The post The FDA Often Doesn’t Test Generic Drugs for Quality Concerns, So ProPublica Did appeared first on ProPublica.
Drugs currently shortage FDA total 75 as of Dec. 30, down from 194 in June, mainly hospital injectables and acute care meds.
ABC 11 Raleigh, NC on MSN
New pill form of weight-loss drug Wegovy to be manufactured in the Triangle
A popular weight loss drug made in the Triangle is now available in pill form. On Monday, pharmaceutical company Novo Nordisk ...
The U.S. Food and Drug Administration (FDA) on Thursday announced FDA PreCheck, a program developed in response to a recent executive order signed by President Donald Trump to encourage domestic drug ...
Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...
Pharmaceutical Technology on MSN
Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis
Cellenkos has received orphan drug designation from the US FDA for its investigational CK0804 Treg therapy to treat ...
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