Life Sciences Legal Insights
I came in like a wrecking ball…
Big changes are coming to HHS, FDA, and CMS. How those changes play out no...
A New Day Coming for U.S. Biotech
After the sweeping results of the election on November 5, 2024, all sectors of business...
Happy Veterans Day!
Take this day to reflect, honor, and remember that freedom is not free! Be sure...
Approval in U.K. for new Alzheimer’s drug, but not approved for reimbursement in U.K. National Health Service
On October 23, 2024, the U.K. Medicines and Healthcare products Regulatory Agency announced approval of...
UPDATE: FDA to reconsider tirzepatide shortage decision in response to litigation from Industry
On October 7, 2024, the Outsourcing Facilities Association (OFA) filed litigation against FDA in the...
Shortage resolved for Eli Lilly’s GLP-1, tirzepatide-compounders reminded of restrictions
FDA announced on October 2, 2024 that the shortage had been resolved for Eli Lilly's...