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Agency Actions

Lifestyle Apps Will Be Officially Free of FDA Regulation
Roche Drug Outperformed Standard of Care in Phase 2 Study
Can Detect Presence of Cancer at Stage I
Cases Projected to Increase From 16.5 Million to 27.0 Million by 2030
Lifesaving Life Foam for Battlefield, Terrorist Attacks, Trauma
Cell Reprogramming Process May Benefit Patients Prone to Severe Hypoglycemia
Combination Pain Reliever Slated for August 2019 Approval
Devastating Pediatric Disease Can Cause CNS Dysfunction
Artificial Intelligence Enables Platform to Detect Amyloid PET Status
Inhaled Form of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
FDA Gives Priority Regulatory Review of Diagnostic for Fast-Progressing Kidney Disease
Rare, Life-threatening Disease Has No Approved Treatment
Superior to Quinine in Reducing Mortality in Two Clinical Trials
May Offer Improved Safety Profile for Pediatric Patients
KardiaMobile Receives Two More Clearances for Arrhythmia Detection
Possible First Treatment Option for Rare Autoimmune Disease of the CNS
Current, Sole Therapy Not Always Successful/Suitable
Over 1.5 Million Americans Likely to have Wet AMD by 2020 
First Patient Expected to Receive AMT-130 Therapy in 2019
Incurable Genetic Condition Affects One in 3-4,000 People
First-in-Human Phase 1 Trial Will Begin This Year
Aggressive T-cell Prolymphocytic Leukemia Has Very Limited Treatment Options
Subcutaneous Agent Could Prevent Laparoscopic Surgery, Emergency Surgery
Pre-clinical Trials Showed Drug Inhibits Fibroblast Activity and Collagen Deposition
MP-101 Has Potential to Drastically Alter Disease Progression
ACE-083 May Improve Strength in Target Muscles, Enhance Quality of Life
FDA, CDC, and CMS Team Up To Improve Disaster Response Planning