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Clinical Trials

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy ParticipantsClinical TrialsSep 21st 2023

A Phase 1 Study of Inhaled KB408 for the Treatment of Alpha-1 Antitrypsin DeficiencyClinical TrialsSep 21st 2023

A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male ParticipantsClinical TrialsSep 21st 2023

Comparative Study Between Preoperative and Postoperative Rectal MisoprostolClinical TrialsSep 21st 2023

Factors Affecting Physical Activity in StrokeClinical TrialsSep 21st 2023

Industry News

Pfizer's Russian profit pledge bears fruit with $5M initial gift, CEO saysFiercePharmaJun 22nd 2022

Moderna, plotting production moves worldwide, taps UK for next mRNA pushFiercePharmaJun 22nd 2022

Should Merck buy Seagen—and at what price? Analysts and investors weigh inFiercePharmaJun 22nd 2022

Enanta sues Pfizer for infringement on Paxlovid, citing a patent it was granted a week ago FiercePharmaJun 22nd 2022

ViiV, Gilead and Janssen notch top scores with HIV/AIDS patient groups; pricing, access still pain pointsFiercePharmaJun 22nd 2022

FDA Enforcement Reports

This Recall RSS Feed Retiring Soon, New Subscription Service AvailableEnforcement Reports DevicesJul 28th 2023

Enforcement Report for the Week of April 19, 2023Enforcement Reports DevicesJul 27th 2023

Enforcement Report for the Week of July 26, 2023Enforcement Reports DevicesJul 25th 2023

Enforcement Report for the Week of July 19, 2023Enforcement Reports DevicesJul 18th 2023

This Recall RSS Feed Retiring Soon, New Subscription Service AvailableEnforcement Reports DevicesJul 16th 2023

FDA Criminal Investigations Press Releases

Former Traveling Nurse Pleads Guilty to Tampering with MorphineCriminal Investigations Press ReleasesNov 8th 2024

China-Based Chemical Company, Its Director and Senior Employees Indicted for Alleged Fentanyl Manufacturing and DistributionCriminal Investigations Press ReleasesNov 8th 2024

Spa Owner Arrested for Allegedly Performing Thousands of Illegal Counterfeit Injections on Clients for Over Three YearsCriminal Investigations Press ReleasesNov 1st 2024

Florida Company Pleads Guilty to Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 PandemicCriminal Investigations Press ReleasesOct 30th 2024

California Company Charged with Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 PandemicCriminal Investigations Press ReleasesOct 29th 2024

FDA MedWatch Safety Alerts

2023 Medical Device RecallsMedWatch Safety AlertsMar 6th 2024

2024 Medical Device RecallsMedWatch Safety AlertsMar 6th 2024

Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in ManufacturingMedWatch Safety AlertsMar 6th 2024

Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety CommunicationMedWatch Safety AlertsMar 6th 2024

Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter Disconnection from the Patient Line Stopcock ConnectorsMedWatch Safety AlertsMar 6th 2024

ORA FOIA Electronic Reading Room

Avenue Pharmacy Inc dba Pathway Pharmacy. Ocala, FL. 483 issued 10/04/2024Office of Regulatory Affairs (ORA) FOIA Electronic Reading RoomNov 6th 2024

Brookfield Medical Surgical Supply Inc. Brookfield, CT. Untitled Letter issued 09/27/2024Office of Regulatory Affairs (ORA) FOIA Electronic Reading RoomNov 6th 2024

Staska Pharmaceuticals, Inc. Bennett, NE. 483 issued 09/18/2024Office of Regulatory Affairs (ORA) FOIA Electronic Reading RoomNov 5th 2024

Shandong Boyuan Pharmaceutical Co. Ltd. - 10/17/2024 Office of Regulatory Affairs (ORA) FOIA Electronic Reading RoomNov 4th 2024

Aarti Drugs Limited - 9/20/2024Office of Regulatory Affairs (ORA) FOIA Electronic Reading RoomNov 1st 2024