United States Food and Drug Administration

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

16 hours ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics

FDA Imposes Boxed Warning and Restricts Use of Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

1 day ago talkbio0Tagged Black Box Warning, ELEVIDYS, gene therapy, Indication restriction, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Post-marketing study, Safety labeling, United States Food and Drug Administration

Elevidys; Sarepta Therapeutics; Duchenne muscular dystrophy; FDA; Boxed warning; Gene therapy; Acute liver failure; Safety labeling; Indication restriction; Post-marketing study

Nuvalent Shares Positive Phase 1/2 ALK Inhibitor Data Rivaling Pfizer’s Lorbrena in Lung Cancer

2 days ago talkbio0Tagged ALK Inhibitor, ALKOVE-1 trial, Clinical Trials, CNS activity, Frequency of Responses, Lorbrena, lorlatinib, neladalkib, Non-Small Cell Lung Carcinoma, Nuvalent, Phase 1/2 data, United States Food and Drug Administration

Nuvalent; neladalkib; ALK inhibitor; ALKOVE-1 trial; Phase 1/2 data; non-small cell lung cancer (NSCLC); lorlatinib; Lorbrena; FDA; clinical trial; objective response rate; CNS activity

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

2 days ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

2 days ago talkbio0Tagged ARC-EX System, CE Mark, Clearance, hand sensation, Hand Strength, Home Use, Medical Devices, Medical service, neurotechnology, ONWARD, Spinal Cord Injuries, United States Food and Drug Administration

ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced ROSA Knee Robotic Technology

2 days ago talkbio0Tagged Clearance, OptimiZe technology, Personalized, robotic knee replacement, ROSA Knee, surgical planning, United States Food and Drug Administration, Zimmer Biomet

Zimmer Biomet; FDA clearance; ROSA Knee; OptimiZe technology; robotic knee replacement; personalized surgical planning

Merck Again Brings Out Big Bucks, Buys Cidara in $9.2B Antiviral Push

4 days ago talkbio0Tagged Acquisition, Antiviral Agents, Breakthrough Therapy, CD388, Cidara Therapeutics, Influenza, J&J, Merck, Phase 3, sanofi, United States Food and Drug Administration

Merck; Cidara Therapeutics; CD388; antiviral; acquisition; influenza; phase 3; FDA Breakthrough Therapy; J&J; Sanofi; Keytruda

FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

5 days ago talkbio0Tagged Center for Drug Evaluation, Center for Drug Evaluation and Research, Drug Approval, George Tidmarsh, leadership instability, OCE, Oncology Center of Excellence, Project, regulatory reform, research, review delays, Richard Pazdur, United States Food and Drug Administration

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

FDA Unveils ‘Plausible Mechanism Pathway’ to Accelerate Personalized Therapies, Inspired by Baby KJ

6 days ago talkbio0Tagged Baby KJ, Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, Infrequent, mechanism pathway, personalized therapies, regulatory innovation, United States Food and Drug Administration

FDA; personalized therapies; gene editing; plausible mechanism pathway; Baby KJ; rare diseases; CRISPR; regulatory innovation

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA Plan, Launching Its Hyper-Precise Aortic Care Platform

6 days ago talkbio0Tagged AiORTA, Anatomical segmentation, Aortic Aneurysm, automated aortic surgery, Clearance, Clinical, cloud-based healthcare, hyper-precise aortic care, Infantile Neuroaxonal Dystrophy, measurement automation, Medical service, Preoperative, United States Food and Drug Administration, vascular AI, ViTAA, workflow improvement

ViTAA Medical; FDA 510(k) clearance; AiORTA Plan; hyper-precise aortic care; automated aortic surgery planning; vascular AI; preoperative measurement automation; cloud-based healthcare; aortic aneurysm segmentation; clinical workflow improvement