A Bloomberg newsletter covering India reports that Indian drug firms are sharing FDA inspection reports and their responses in an effort to improve in...
FDA grants Sarepta Therapeutics an accelerated approval for its BLA for Elevidys, the first gene therapy for treating pediatric patients aged four thr...
A 10/2022 inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL leads to a just-posted seven-item Form FDA-483 that cites significant...
FDA clears an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies.
FDA approves Sebelas Suflave colonoscopy prep that reportedly tastes like a sports drink and thus is easier to use.
Five stakeholders express appreciation for a revised FDA draft guidance on pharmacogenomic data submissions and suggest changes to it.
FDA approves Boehringer Ingelheims Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatments for improving bloo...
Twenty-five bipartisan House representatives urge FDA to create patient-centered policies on compounded hormones that maintain patients access to care...
