FDA has Accepted Application for Rare Epilepsy

September 21st 2021

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.

AbbVie Submits Skyrisi to FDA for Crohn’s Disease

September 21st 2021

In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy

FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma

September 21st 2021

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

FDA Approves First Biosimilar to Treat Macular Degeneration

September 20th 2021

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

CMS Assigns J-Code for the Antibiotic Kimyrsa

September 20th 2021

Effective October 1, 2021, CMS will reimburse for the infusion product when dispensed in the outpatient setting.