Intellectual Product

FDA Breakthrough Designations Lead to Priority Reviews, Report Finds

23 hours ago talkbio0Tagged biotechnology innovation, Breakthrough Therapy, CDER, Drug Approval, expedited pathway, Identifier, Infrequent, Neoplasms, Priority Review, regulatory science, United States Food and Drug Administration

FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science

Edgewise Therapeutics Appoints Christopher Martin to its Board of Directors

1 day ago talkbio0Tagged Acquisition, Becker Muscular Dystrophy, board of directors, cardiovascular asset, Christopher Martin, commercial, Edgewise Therapeutics, executives, Leadership, Merck, Verona Pharma

Edgewise Therapeutics; Christopher Martin; Board of Directors; biotech executive; commercial leadership; Becker muscular dystrophy; cardiovascular asset; Verona Pharma; Merck acquisition

EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

2 days ago talkbio0Tagged algorithm, Clearance, Edap, Malignant neoplasm of prostate, Medical Devices, robotic HIFU, United States Food and Drug Administration

EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

2 days ago talkbio0Tagged acceptance, ARROS-1 trial, Breakthrough Therapy, Clinical Nurse Specialists, Identifier, New Drug Application, Non-Small Cell Lung Carcinoma, Nuvalent, orphan drug designation, PDUFA, Penetration, pre-treated, Protein-tyrosine kinase inhibitor, ROS1-positive, United States Food and Drug Administration, zidesamtinib

Nuvalent; zidesamtinib; FDA acceptance; New Drug Application (NDA); ROS1-positive NSCLC; tyrosine kinase inhibitor (TKI) pre-treated; ARROS-1 trial; PDUFA date; CNS penetration; breakthrough therapy designation; orphan drug designation

MediKarma Scales Its Clinical And Commercial Acumen With Appointment Of Dr. Scott Howell As Chief Clinical Officer And Angela Breton As Chief Revenue Officer

3 days ago talkbio0Tagged AI-driven, Angela Breton, Chief Clinical Officer, Chief Revenue Officer, MediKarma, Patient data, Platform, proactive care, Scott Howell

MediKarma; Scott Howell; Angela Breton; Chief Clinical Officer; Chief Revenue Officer; AI-driven platform; patient data; proactive care

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

3 days ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Eli Lilly Signs Up to $2.6 Billion Deal with South Korean Biotech for RNA Medicine Delivery

5 days ago talkbio0Tagged cardiometabolic, Deal Value, eli lilly, LEAD platform, Metabolic Diseases, News [Publication Type], Pharma, RNAi medicines, SanegeneBio, South Korean biotech, strategic partnership

Eli Lilly; SanegeneBio; South Korean biotech; RNAi medicines; metabolic diseases; LEAD platform; strategic partnership; cardiometabolic; deal value; pharma news

Merck Q3 2025: Solid Organic Growth Across All Sectors

1 week ago talkbio0Tagged Acquisition, Animal Health, Gross margin, Keytruda, Merck, Neoplasms, new product, organic growth, Pharma, Q3 2025, Verona

Merck; Q3 2025; Organic growth; KEYTRUDA; Oncology; Animal Health; Verona Pharma acquisition; Gross margin; Revenue; New product launches

AnaptysBio Halts Phase 2 Ulcerative Colitis Trial; Lyell Immunopharma Secures CAR-T Rights

2 weeks ago talkbio0Tagged AnaptysBio, CAR-T therapy, Clinical Failure, Clinical Trials, Discontinuation (procedure), Lyell Immunopharma, News [Publication Type], Phase 2 trial, Rheumatoid Arthritis, Rosnilimab, Ulcerative Colitis

AnaptysBio; rosnilimab; ulcerative colitis; Phase 2 trial; clinical failure; trial discontinuation; Lyell Immunopharma; CAR-T therapy; licensing deal; biotech news; rheumatoid arthritis

Spotlight On: What to Watch at AHA 2025 – Key Science and Trends

2 weeks ago talkbio0Tagged 2025, Autoimmune hemolytic anemia, Cardiology discipline, cardiometabolic, Cardiopulmonary Resuscitation, Clinical Trials, coronary trials, gene editing therapies, Guidelines, Hypertensive disease, Interventional procedure, lipid management, Medical Valves, polypill, Science

AHA 2025; late-breaking science; clinical trials; cardiology; gene-editing therapies; polypill; lipid management; valve and coronary trials; cardiometabolic intervention; hypertension; CPR guidelines