On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertio
Similar Posts
Pharmcore Inc. dba Hallandale Pharmacy. Fort Lauderdale, FL. 483 issued 06/13/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/13/2025
Short Title (70 char) Pharmcore Inc. dba Hallandale Pharmacy. Fort Lauderdale, FL. 483 issued 06/13/2025
FEI Number 3014480778
Firm Name Pharmcore Inc. dba Hallandale Pharmacy
Record Type 483
State FLDiversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical StudiesBreathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings
Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or deathFDA Responses to Action Items Identified in 2023 Intergovernmental Working Meeting on Drug Compounding
In the most recent Intergovernmental Working Meeting on Drug Compounding, Nov. 7-8, 2023, FDA and state regulators identified three actions items. This page contains a summary of those action items and how FDA has responded.Compounding Quality Center of Excellence | Instructor-Led Trainings
The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
FEI Number 3010589333
Firm Name Right Value Drug Stores, LLC
Record Type 483
State TX
Establishment Type Outsourci
