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FDA
377 Articles Available
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FDA
Statement Alerting Patients and Health Care Professionals of NDMA Found in Samples of Ranitidine
PR-M09-19-NI-043
Fast Track Designation
FDA Grants Fast Track Designation for Farxiga in Heart Failure
PR-M09-19-NI-042
FDA Clearance
New Vision System for Tracking Eye Movement Gets FDA Clearance
PAO-M09-19-NI-014
Safety Warning
Patient Deaths Lead to FDA Safety Warning on Hepatitis C Medication
PAO-M09-19-NI-011
FDA Warning
FDA Sends Warning to Company for Selling Unapproved Umbilical Cord Products
PR-M09-19-NI-015
Wearables
First-ever: FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure
PR-M08-19-NI-091
FDA Approval
FDA Approves New Add-on Drug to Treat Off Episodes in Adults with Parkinson’s disease
PR-M08-19-NI-090
Fast Track Designation
FDA Grants Fast Track Designation for Farxiga in Chronic Kidney Disease
PR-M08-19-NI-084
Licensing
Ionis Licenses Hepatitis B Program to GSK
PR-M08-19-NI-085
M&A
AstraZeneca Agrees to Buy US FDA Priority Review Voucher from Sobi
PR-M08-19-NI-083
Regulatory
Are EMA and FDA Decisions Diverging?
PAO-M08-19-NI-037
FDA Approval
AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis
PR-M08-19-NI-073
FDA Breakthrough
Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
PR-M08-19-NI-071
FDA Update
Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder
PR-M08-19-NI-064
FDA Approval
FDA Approves New Antibiotic to Treat Community-Acquired Bacterial Pneumonia
PR-M08-19-NI-061
Pediatric
FDA Approves First of its Kind Device to Treat Pediatric Patients with Progressive Idiopathic Scoliosis
PR-M08-19-NI-054
FDA Approval
FDA Approves New Device to Improve Symptoms in Patients with Advanced Heart Failure
PR-M08-19-NI-055
FDA Approval
FDA Approves New Drug for Treatment-Resistant Forms of Tuberculosis that Affects the Lungs
PR-M08-19-NI-051
Robotic Surgery
Questions About Robotic Surgery Emerge
PAO-M08-19-NI-022
Orphan Drug Designation
Dynacure Receives Orphan Drug Designation from the US FDA for DYN101, an Antisense Medicine to Treat Rare Disease 'Centronuclear Myopathies'
PR-M08-19-NI-039
Novartis Stands Behind Zolgensma® (onasemnogene abeparvovec-xioi) for the Treatment of Children Less than 2 Years of Age with Spinal Muscular Atrophy
PR-M08-19-NI-023
Marketing
Visual Marketing Strategy for Libtayo
PAO-M08-19-NI-005
FDA
FDA Says No to Farxiga for Type 1 Diabetes
PAO-M08-19-NI-002
FDA Approval
FDA Approves Bayer's Nubeqa® (darolutamide) for Prostate Cancer
PR-M08-19-NI-001
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