United States Food and Drug Administration – Page 5

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

4 weeks 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

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

4 weeks ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis

FDA Moves to Remove Black Box Warnings from Menopausal Hormone Therapies

4 weeks ago talkbio0Tagged Black Box Warning, estrogens, Hormone replacement therapy, Hormone Therapy, labeling change, Menopausal symptom, Menopause, Progestins, United States Food and Drug Administration, women 's health

FDA; menopause; hormone therapy; black box warning; HRT; estrogen; progestogen; labeling change; women’s health; menopausal symptoms

Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

4 weeks ago talkbio0Tagged bezuclastinib, Cogent Biosciences, Effectiveness, Frequency of Responses, Gastrointestinal Stromal Tumors, Infrequent, Malignant neoplasm of stomach, Progression-Free Survival, second-line treatment, Submission, United States Food and Drug Administration

Cogent Biosciences; bezuclastinib; unprecedented efficacy; rare stomach cancer; gastrointestinal stromal tumor (GIST); FDA submission; second-line treatment; objective response rate; progression-free survival

Merck Reports Pivotal PCSK9 Pill Data in Race to Beat AstraZeneca to Market

4 weeks ago talkbio0Tagged Approved, AstraZeneca, Autoimmune hemolytic anemia, Cardiovascular Diseases, CORALreef trial, enlicitide, LDL-C, Merck, oral cholesterol pill, PCSK9 inhibitor, United States Food and Drug Administration

Merck; PCSK9 inhibitor; enlicitide; oral cholesterol pill; AstraZeneca; CORALreef trial; LDL-C reduction; AHA 2025; FDA approval; cardiovascular disease

Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease

4 weeks ago talkbio0Tagged Antisense Oligonucleotides, curative potential, Hypertriglyceridemia, Ionis, Pancreatitis, Acute, Phase 3 Clinical Trials, RNA-targeted therapy, Severe (severity modifier), Submission, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy

FDA Extends Review Period for Rhythm Pharmaceuticals’ Imcivree (Setmelanotide) in Acquired Hypothalamic Obesity

1 month ago talkbio0Tagged Agonist, amendment, goal, Hypothalamic structure, Imcivree, MC4R protein, human, PDUFA, Phase 3 trial, review extension, Rhythm Pharmaceuticals, setmelanotide, United States Food and Drug Administration

Imcivree; Rhythm Pharmaceuticals; FDA; review extension; acquired hypothalamic obesity; setmelanotide; PDUFA goal date; Phase 3 trial; major amendment; MC4R agonist

Patient Hospitalized After Receiving Intellia’s CRISPR Therapy Dies, Prompting FDA Hold on Trials

1 month ago talkbio0Tagged Amyloidosis, Clinical Trials, Comorbidity, CRISPR therapy, Intellia, Liver, nex-z, nexiguran ziclumeran, Patient Death, Phase III MAGNITUDE trial, Toxicity aspects, TTR wt Allele, United States Food and Drug Administration

Intellia Therapeutics; CRISPR therapy; nexiguran ziclumeran (nex-z); patient death; liver toxicity; Phase III MAGNITUDE trial; ATTR amyloidosis; clinical trial hold; FDA; comorbidities

Weight-loss Drugs Lead Latest Batch of FDA Priority Voucher Recipients

1 month ago talkbio0Tagged Commissioner 's National Priority Voucher, drug price, eli lilly, fast-track approval, Nordisk, priority review vouchers, United States Food and Drug Administration, Wegovy, Weight-Loss Agents

FDA; priority review vouchers; weight-loss drugs; Wegovy; orforglipron; Eli Lilly; Novo Nordisk; drug pricing; fast-track approval; Commissioner’s National Priority Voucher

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

1 month ago talkbio0Tagged Approved, AQUILA study, daratumumab, Darzalex Faspro, Early Intervention (Education), high-risk, Progression-Free Survival, Smoldering myeloma, United States Food and Drug Administration

FDA approval; Darzalex Faspro; high-risk smoldering multiple myeloma; AQUILA study; early intervention; progression-free survival; daratumumab; hyaluronidase-fihj