New Rare Antibiotic Drugs Get Faster FDA Approval Pathway

Patients with life-threatening infections and no treatment options may have a better shot at getting needed drugs under a new, faster antibiotics pathway the FDA completed Wednesday.

Companies making antibiotics for small patient populations will be able to use smaller, more streamlined clinical trials, the Food and Drug Administration said Wednesday. The guidance gives companies more clarity on what is expected when applying for the faster antibiotic approval process. The pathway is the agency’s latest push to generate more novel antibiotics, which typically aren’t high on companies’ priority lists because they don’t make a lot of money.

“The decline in ...