FDA Layoffs Impact Neuralink Trials and Medical Device Approvals
FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...
Positive Long-Term Outlook for Narrow-Moat Siegfried as Drug Outsourcing Demand Remains Strong
We assign Siegfried a Medium Morningstar Uncertainty Rating. Its business is relatively stable, with high switching costs and good visibility due to long-term customer contracts. However, small ...
Lawyer questions oversight of hyperbaric oxygen chambers after fire kills 5-year-old boy
Annie Cooper, of Royal Oak, couldn't free her 5-year-old son, Thomas, from a hyperbaric chamber as flames engulfed him on the ...
FiercePharma15h
Regulatory tracker: Europe approves CSL's HAE drug, Arcturus-partnered COVID vaccine
Welcome to Fierce Pharma's regulatory tracker for the first ... with HR+/HER2- early breast cancer. Last fall, the drug picked up an FDA nod in patients with HR+/HER2- early breast cancer based ...
Medscape19h
FDA Okays New Rapid-Acting Biosimilar Insulin for Diabetes
The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog ...
The National Law Review23h
One Month in for Trump Administration II: What Do We Know About the FDA?
With RFK Jr.’s confirmation hearings in process, we are keeping our fingers on the pulse. Polsinelli’s seasoned FDA practitioners and special guest, Wayne Pines, will be re-convening for part two of ...