News

STAT2d
FDA names drug regulator Tidmarsh acting head of biologics center after Prasad’s exit
George Tidmarsh is taking on more responsibilities at FDA after the sudden departure of top official Vinay Prasad.
US FDA declines to approve Regeneron's blood cancer therapy for second time
Regeneron said on Friday the U.S. Food and Drug Administration has once again declined to approve its blood cancer therapy, ...
Healio1d
FDA approves vagus nerve stimulator for rheumatoid arthritis
The FDA has approved the SetPoint System, a vagus nerve stimulator from SetPoint Medical, for the treatment of rheumatoid ...
STAT21h
FDA to stress opioids’ risk of overdose, death in new medication safety labels
The FDA will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning ...
The FDA Is Sounding The Alarm On 7-OH Kratom Products. Here’s Why.
7-OH occurs naturally at low levels in the kratom plant, but the FDA is most concerned with products that contain 7-OH in ...
WLRN11h
Miami-based healthcare company receives new FDA approval of Parkinson’s treatment
Insightec, the Miami-based innovator in focused ultrasound to transform patient care, announced July 8 the U.S. Food and Drug ...
What is kratom, the addictive drug found at vape shops and gas stations? FDA takes action
The FDA has released a report to educate the public regarding the dangers of 7-OH and its distinction from the kratom plant leaf.
PharmExec20h
FDA Approves Label Update for Novartis’ Leqvio to Enable Twice-Yearly Monotherapy for LDL-C Management in Adults with Hypercholesterolemia
The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein ...