Tag Archive for: patient safety

Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.

The investigational drug in question, fasinumab, was being evaluated in late-stage studies for the treatment of osteoarthritis of the knee or hip and chronic low back pain in patients with concomitant osteoarthritis of the knee or hip.

The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months.

Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.

India is testing samples of cough syrups produced by Maiden Pharmaceuticals after the World Health Organization said its products were linked to the deaths of dozens of children in Gambia, a government official said on Thursday.

The agency put the partial hold after a serious adverse event was seen in a patient during the study.

The company stated that it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.

The report summarizes various measures of the pharmaceutical industry’s ability to deliver quality drugs to U.S. patients and consumers.

The agency said it received more than 48,000 reports of faulty Dutch medical equipment maker Philips’ ventilators and respiratory devices between May and July of this year.

Shares in GSK, Sanofi and Haleon fell sharply on Thursday, following declines earlier this week, amid growing concerns about U.S. litigation over a heartburn drug that was pulled from the market in 2020 for containing a probable carcinogen.