New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier

June 29th 2022

The FDA is accepting comments on the proposed rule through Oct. 26, 2022.

Sanofi Lowers Insulin Price

June 29th 2022

Sanofi has lowered the out-of-pocket cost of its insulins to $35 for a 30-day supply through the company’s savings program.

FDA Accepts sBLA for Eylea in Diabetic Retinopathy

June 29th 2022

Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.

FDA Issues Complete Response Letter for UTI Therapy

June 28th 2022

Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.

CVS Caremark Drops Several Products from Drug List

June 28th 2022

Effective July 1, 2022, CVS Caremark has removed seven drugs and added 14 to its Standard Control Formulary.