United States Food and Drug Administration – Page 3

White House Requests Resignation of Top FDA Aide, Prompting Tensions with Commissioner Makary

2 weeks ago talkbio0Tagged CHARGE Syndrome, controversy, internal tensions, management technique, Marty Makary, resignation, Sanjula Jain-Nagpal, United States Food and Drug Administration, White House, Workforce - population group

FDA; White House; Marty Makary; Sanjula Jain-Nagpal; resignation; HHS; staffing controversy; Robert F. Kennedy Jr.; management style; internal tensions

FDA Grants Regeneron Two Eylea HD Approvals in One Day

2 weeks ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Regeneron, Retinal Vein Occlusion, RVO, United States Food and Drug Administration

Regeneron; FDA approval; Eylea HD; macular edema; retinal vein occlusion; monthly dosing; aflibercept; ophthalmology; RVO

FDA Breakthrough Designations Lead to Priority Reviews, Report Finds

2 weeks ago talkbio0Tagged biotechnology innovation, Breakthrough Therapy, CDER, Drug Approval, expedited pathway, Identifier, Infrequent, Neoplasms, Priority Review, regulatory science, United States Food and Drug Administration

FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science

EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

2 weeks ago talkbio0Tagged algorithm, Clearance, Edap, Malignant neoplasm of prostate, Medical Devices, robotic HIFU, United States Food and Drug Administration

EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices

FDA Approves New Indication and Monthly Dosing for Regeneron’s Eylea HD

2 weeks ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Pre-filled Syringe, Regeneron, Retinal Diseases, Retinal Vein Occlusion, United States Food and Drug Administration

FDA approval; Eylea HD; Regeneron; macular edema; retinal vein occlusion; monthly dosing; ophthalmology; aflibercept; retinal diseases; pre-filled syringe

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

2 weeks ago talkbio0Tagged acceptance, ARROS-1 trial, Breakthrough Therapy, Clinical Nurse Specialists, Identifier, New Drug Application, Non-Small Cell Lung Carcinoma, Nuvalent, orphan drug designation, PDUFA, Penetration, pre-treated, Protein-tyrosine kinase inhibitor, ROS1-positive, United States Food and Drug Administration, zidesamtinib

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FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

3 weeks ago talkbio0Tagged bioequivalence, Data Fidelity, GDUFA IV, Manufacturing, Metric (substance), onshoring, Performance, public health medicine (field), United States Food and Drug Administration, user fee

FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

3 weeks ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx PCR Platform to Support Submission to the U.S. FDA

3 weeks ago talkbio0Tagged Clinical Evaluations, Co-Diagnostics, Co-Dx PCR platform, COVID19 (disease), Flu A/B, multiplex test, point-of-care, regulatory submission, Respiratory syncytial virus, United States Food and Drug Administration

Co-Diagnostics; clinical evaluations; multiplex test; point-of-care; Co-Dx PCR Platform; FDA 510(k); Flu A/B; COVID-19; RSV; regulatory submission

Scott Gottlieb, M.D., Joins UnitedHealth Group Board of Directors

3 weeks ago talkbio0Tagged board of directors, Health care facility, Health Policy, innovation, medical breakthroughs, Patient access, Scott Gottlieb, Technology, United States Food and Drug Administration, UnitedHealth Group

Scott Gottlieb; UnitedHealth Group; Board of Directors; FDA; health policy; innovation; patient access; medical breakthroughs; technology in healthcare