Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024.

Food and Drug Administration 52

Food and Drug Administration FDA Food Management 52

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has accepted Ipsen’s supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. Onivyde works by blocking an enzyme called topoisomerase I, which is involved in copying cell DNA.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. MELODY clinical trials evaluating nirsevimab.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

Pharmaceutical Technology

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59