Tag: Food & Drug Administration
FDA Head Asks for Investigation Into Alzheimer Disease Drug Approval
Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol
New Rx Instructions Tighten Use of Controversial Alzheimer Disease Drug
Major changes to prescribing instructions are rare, especially so soon after approval; change could curb the drug's use
Lilly to Seek FDA Approval for New Drug for Alzheimer Disease
Donanemab has already received a 'breakthrough therapy' designation from the FDA
FDA Approves StrataGraft for Deep Partial-Thickness Thermal Burns
Data show StrataGraft helps reduce the amount of healthy skin needed for grafting
Three FDA Advisers Quit Over Agency Approval of Aduhelm
Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness
FDA Approves Aduhelm for Alzheimer Disease
Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial
FDA Plans to Approve Pfizer Vaccine for Those Aged 12 Years and Older
Pfizer's trial in adolescents showed its vaccine worked as well in teens as it does in adults
Farxiga Approved to Reduce Risk for CKD Progression
SGLT2 inhibitor approved for patients with CKD to prevent kidney function decline, kidney failure, CV death, hospitalization for heart failure
FDA Approves Higher-Dose Naloxone Hydrochloride Nasal Spray
8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses
FDA Approves Immunotherapy for dMMR Endometrial Cancer
Jemperli approved for dMMR endometrial cancer that progressed after platinum-containing chemotherapy treatment
