Amino Acid, Peptide, or Protein

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

2 days 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

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

2 days 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

2 days 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

2 days 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

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

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

Lilly Prepares Amylin-Based Obesity Drug Eloralintide for Phase III After Strong Weight Loss Results

3 days ago talkbio0Tagged Agonist, Amylin, Clinical Development, Eli, Eli Lilly, Eloralintide, Obesity Drug, Phase 3 Clinical Trials, Weight Loss

Eli Lilly; eloralintide; amylin agonist; obesity drug; Phase III trial; weight loss; clinical development

Pharma Investment Surge in US Manufacturing Creates Major Opportunities for CDMOs

3 days ago talkbio0Tagged Advanced therapies, alpha 1-antitrypsin, Biological Factors, capital investment, CDMOs, eli lilly, Growth, Johnson & Johnson, Market, pharmaceutical manufacturing, production, supply chain, U.S.

US pharmaceutical manufacturing; CDMOs; capital investment; Johnson & Johnson; Eli Lilly; biologics; API production; supply chain; advanced therapies; market growth

Closed Loop Medicine Secures Additional Key GLP-1 Patent for Its AI-Based Dosing Platform: Powering Personalized, Direct-to-Patient Therapies

4 days ago talkbio0Tagged adaptive dosing, AI-based, Closed Loop Medicine, dosing, Glucagon-Like Peptide 1, incretin drugs, Legal patent, personalized therapies, semaglutide, WeDosify

Closed Loop Medicine; GLP-1; patent; AI-based dosing; personalized therapies; semaglutide; incretin drugs; WeDosify; adaptive dosing; direct-to-patient

Metsera Bidding War Grips Obesity Drug Field as Novo Nordisk and Pfizer Escalate Offers

4 days ago talkbio0Tagged Acquisition, Antitrust, bidding war, Disputes, Dominance, Glucagon-Like Peptide 1, Legal, Market, Metsera, Novo Nordisk, Obesity, Pfizer

Metsera; obesity drugs; bidding war; Novo Nordisk; Pfizer; acquisition; GLP-1; antitrust; market dominance; legal disputes