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FDA
309 Articles Available
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FDA Approval
Second Generation On-the-Go ECG Device Gets FDA Approval
PAO-M05-19-NI-023
FDA Approval
FDA Approves Venetoclax for CLL and SLL
PR-M05-19-NI-057
Drug Approval
U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease
PR-M05-19-NI-036
FDA
The FDA Changes the Drug Approval Process
PAO-M05-19-NI-014
Oncology
FDA Will Use Real-Time Oncology Review for Prostate Cancer Drug
PAO-M05-19-NI-012
FDA
Gluten-Free Food Labeling: Important Information for Those with Celiac Disease
PR-M05-19-NI-029
FDA
FDA Grants Breakthrough Device Designation to Natera's Signatera Test
PR-M05-19-NI-025
Appointment
CHOP Anesthesiologist Appointed to FDA Advisory Committee
PR-M05-19-NI-024
FDA Statement
Statement from FDA on New Efforts to Protect Women's Health and Help to Ensure the Safety of Breast Implants
PR-M05-19-NI-016
FDA
FDA Purchases Bundle of ADMET Predictor® Licenses
PR-M05-19-NI-012
Generic
First Generic Nalaxone Nasal Spray Approved by FDA
PAO-M05-19-NI-006
ADHD
First Medical Device Cleared by FDA to Treat Childhood ADHD
PAO-M05-19-NI-002
FDA Approval
FDA Approved Keytruda for Kidney Cancer Sooner than Expected
PAO-M05-19-NI-001
FDA Approval
FDA Approves Trade Name Lexette (TM) (Halobetasol Propionate) Foam, 0.05%
PR-M05-19-NI-006
FDA Approval
FDA Approves Bausch Health's DUOBRII™ (Halobetasol Propionate And Tazarotene) Lotion 0.01%/0.045% For Plaque Psoriasis In Adults
PR-M04-19-NI-082
Opioids
FDA Grants Competitive Generic Therapy (CGT) Designation to Purdue Pharma’s Investigational Nalmefene HCl Injection
PR-M04-19-NI-080
FDA Statement
Statement from the FDA's Center for Devices and Radiological Health on Reducing Risks Associated with Surgical Staplers
PR-M04-19-NI-074
FDA Approval
J&J’s Bladder Cancer Drug Gets Accelerated FDA Approval
PAO-M04-19-NI-019
FDA Rule
Final Rule Published by the FDA on Consumer Hand Sanitizers
PAO-M04-19-NI-018
FDA Action
FDA Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices
PR-M04-19-NI-060
FDA Statement
FDA Statement from Deputy Commissioner On New Steps to Protect Consumers from Unlawful Ingredients in Dietary Supplements
PR-M04-19-NI-059
FDA Acceptance
Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
PR-M04-19-NI-053
Bone Graft
Collagen Matrix, Inc. Receives FDA 510(k) Clearance of a Bioactive Moldable Bone Graft Matrix
PR-M04-19-NI-051
FDA Approval
FDA Approves First Targeted Therapy for Metastatic Bladder Cancer
PR-M04-19-NI-050
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