Fabre-Kramer Pharmaceuticals

The median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug User Fee Act goals, highlighting the fundamental predictability of the re

The US FDA’s user fee calendar for 2024 already features almost 60 new molecular entities and novel biologics, echoing the agency’s review workload at the beginning of 2023 – a position that contains

The sheer number of US FDA’s novel drug approvals in 2023 contrasts with the generally moderate, steady performance of the Center for Drug Evaluation and Research over the year, including a median rev

Pfizer Inc. can claim two of the three novel agents on the FDA’s user fee calendar for the month of October 2023, the Pink Sheet ’s US FDA Performance Tracker shows. Joining Pfizer’s oral ulcerative