FDA approves a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia who have no other suitable endovascular...
FDA issues its first Postmarket Device Safety-Related Communications report to Congress that details 45 safety-related communications issued in 2022.
The Department of Justice petitions the U.S. Supreme Court asking it to reverse last months decision by the Fifth Circuit Court of Appeals that would ...
FDA gives the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely target currently circ...
AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy in lung cancer patients extended median prog...
FDA and Duke-Margolis Center for Health Policy announce a 9/18-19 two-day public workshop to discuss pregnancy safety studies.
Federal Register notice: FDA seeks participation by industry organizations in selecting nonvoting industry representatives to serve on the Vaccines an...
Federal Register notice: FDA makes available a final guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access S...
