talkbio – Talk Bio

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

5 hours 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

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

5 hours 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

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

5 hours 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

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

5 hours 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

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

6 hours 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

10 hours 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

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

15 hours 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

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

15 hours 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

Immunome Reports Third Quarter 2025 Financial Results and Provides Business Update

17 hours ago talkbio0Tagged B-Cell Lymphomas, Business Update, Cancer Therapeutic Procedure, cash position, Clinical Trials, financial results, Immunome, net loss, pipeline update, Q3, RINGSIDE trial, therapeutic autologous dendritic cells, varegacestat

Immunome; Q3 2025; financial results; business update; pipeline update; cancer therapies; RINGSIDE trial; varegacestat; IM-1021; B-cell lymphoma; clinical trials; ADC; net loss; cash position

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

17 hours ago talkbio0Tagged BEACON-IPF, cash reserves, Clinical Trials, development expenses, financial results, net loss, oncology program, Oxford Finance, Pliant Therapeutics, PLN-101095, Q3, research

Pliant Therapeutics; Q3 2025 financial results; PLN-101095; oncology program; BEACON-IPF trial; net loss; research and development expenses; cash reserves; Oxford Finance loan repayment