ENTITY – Talk Bio

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

1 day 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 day 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 day 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 day 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

Trump Announces Sweeping Cost Cuts on Lilly and Novo Weight Loss Drugs in Exchange for Medicare Coverage

1 day ago talkbio0Tagged drug price, Eli Lilly ; Novo Nordisk, Glucagon-Like Peptide 1, Medicaid, Medicare, Prices, Transplant Registry Unified Management Program, Wegovy, Weight-Loss Agents, Zepbound

Trump; Eli Lilly; Novo Nordisk; weight loss drugs; GLP-1; Medicare; Medicaid; Wegovy; Zepbound; price cuts; drug pricing deal

Maximizing ROI with Educational Content for Healthcare Marketers: 2025 Trends and Strategies

2 days ago talkbio0Tagged Cell Differentiation process, Data Analytics, digital strategies, Educational content, Feeling content, Health Care Market, Market, Marketing, Metric (substance), Patient Engagement, Performance, personalization, POC, point-of-care, Region of interest:Presence or Identity:Point in time:*:Nominal

healthcare marketing; educational content; ROI; patient engagement; data analytics; AI personalization; point-of-care (POC) marketing; digital strategies; market differentiation; content performance metrics

Eisai Expands Leqembi Subcutaneous Label, Accelerates Early U.S. Launch Progress for Alzheimer’s Disease

2 days ago talkbio0Tagged Alzheimer 's disease, at-home injection, dosing, Eisai, expansion, Labels (device), Leqembi, Maintenance, sBLA, starting dose, status - In progress, Subcutaneous Autoinjector, supplemental biologics, United States Food and Drug Administration

Eisai; Leqembi; subcutaneous autoinjector; label expansion; Supplemental Biologics License Application (sBLA); FDA; maintenance dosing; starting dose; early Alzheimer’s disease; at-home injection; launch progress

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

2 days ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease

Spotlight On Obesity Week: Non-incretin Alternatives Turn Up the Heat

2 days ago talkbio0Tagged Adherence (attribute), Behavior, cardiometabolic, Contrave, craving control, Health, naltrexone-bupropion, non-incretin therapies, pharmaceutical innovation, Weight maintenance regimen

ObesityWeek 2025; non-incretin therapies; naltrexone-bupropion; CONTRAVE; weight management; craving control; behavioral adherence; pharmaceutical innovation; cardiometabolic health

Puma Biotechnology Reports Third Quarter 2025 Financial Results

2 days ago talkbio0Tagged beat, Clinical Trials, EPS, exophthalmos producing substance, financial results, Neoplasms, Nerlynx sales, net income, Puma Biotechnology, Q3, Revenue Decline, revenue guidance

Puma Biotechnology; Q3 2025; financial results; EPS beat; revenue decline; Nerlynx sales; net income; oncology; clinical trials; revenue guidance