October 25th 2024
On October 25, 2024, Kind Pharmaceutical announced receipt of FDA Orphan Drug Designation for AND017 in the treatment of sickle cell disease.
October 23rd 2024
In the complete response letter, the FDA classified deficiencies in the Abbreviated New Drug Application for ketamine as MINOR.
October 17th 2024
Following the approval of sodium oxybate for cataplexy in adults with cataplexy, the FDA approves this indication for the pediatric population.
The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.
October 15th 2024
The Accure Laser System is indicated for long term treatment of patients known to have mild to severe inflammatory acne vulgaris.