This week, two companies announced Class I recalls, the most serious kind, for COVID-19 antigen and antibody tests that have reached the US market without FDA Emergency Use Authorization (EUA) or 510(k) clearance. San Diego-based LuSys Laboratories is recalling...
Certain cancer patients now have access to a new treatment option and companion diagnostic. On March 11, the U.S. Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for treating adults with deleterious or suspected deleterious...
For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency...