FDA Grants Full Approval to Paxlovid to Treat COVID-19
Paxlovid has been taken by seniors and others at high risk for severe COVID-19 under an emergency use approval
FDA News
FDA NEWS
Padcev Plus Keytruda Approved as First-Line Treatment for Urothelial Cancer
Padcev is a Nectin-4-directed antibody and microtubule inhibitor conjugate; Keytruda is a programmed death receptor-1-blocking antibody.
FDA Clears First Ureteroscope With Intrarenal Pressure Monitoring
A pressure sensor at the tip of the ureteroscope provides real-time measurements.
FDA: Patients Should Be Cautious When Using Online Pharmacies to Buy Meds
Red flags include pharmacies that do not require a doctor’s prescription or have a licensed pharmacist to answer questions
FDA Panel Votes on Tenapanor for Hyperphosphatemia in CKD
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
FDA Aims To Improve Medical Device Security
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
FDA Warns of Potential Chemical Exposure With Certain Hemodialysis Machines
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
Use of Extrapolation Common in FDA New Drug Approvals
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
FDA Says No to Vadadustat Approval Due to Safety Concerns
The NDA submission included data from 36 clinical trials involving over 8000 patients.
Black Patients Still Underrepresented in Trials for New Drug Approvals
No improvement seen in representation of Black patients after implementation of a 2015 FDA action plan to improve diversity
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