FDA reminds companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pregnant and Breastfee...
FDA clears a Microbot Medical 510(k) for its Liberty Endovascular Robotic System, a single-use, remotely operated device for peripheral endovascular p...
A MAHA Commission report assessing the health of American children suggests a couple of ways in which FDA could improve the situation.
FDA releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on classification categor...
Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgic...
Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challen...
FDA issues an updated guidance entitled E6(R3) Good Clinical Practice (GCP) that describes GCP principles, emphasizing flexible, modern approaches to ...
New trial data show Eli Lillys Jaypirca (pirtobrutinib) significantly extended progression-free survival in previously untreated patients with chronic...
