Disease or Syndrome

FDA Grants Regeneron Two Eylea HD Approvals in One Day

14 hours ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Regeneron, Retinal Vein Occlusion, RVO, United States Food and Drug Administration

Regeneron; FDA approval; Eylea HD; macular edema; retinal vein occlusion; monthly dosing; aflibercept; ophthalmology; RVO

FDA Breakthrough Designations Lead to Priority Reviews, Report Finds

14 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

Researchers Advance Toward Matching Patients with the Most Effective GLP-1 Drug for Personalized Obesity Treatment

20 hours ago talkbio0Tagged aspects of adverse effects, drug response, Genetic screening method, Glucagon-Like Peptide 1, Machine Learning, Mayo Clinic, MyPhenome, Obesity, personalized care, Precision Medicine, Prediction, Treatment Adherence

GLP-1; precision medicine; obesity; drug response prediction; genetic test; personalized care; side effects; machine learning; MyPhenome; Mayo Clinic; treatment adherence

Edgewise Therapeutics Appoints Christopher Martin to its Board of Directors

20 hours 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

1 day 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

FDA Approves New Indication and Monthly Dosing for Regeneron’s Eylea HD

1 day ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Pre-filled Syringe, Regeneron, Retinal Diseases, Retinal Vein Occlusion, United States Food and Drug Administration

FDA approval; Eylea HD; Regeneron; macular edema; retinal vein occlusion; monthly dosing; ophthalmology; aflibercept; retinal diseases; pre-filled syringe

Agios’ Sickle Cell Trial Falls Short as Mitapivat Fails to Significantly Reduce Pain Crises

2 days ago talkbio0Tagged Agios, Anemia, Sickle Cell, Clinical Trials, hemoglobin response, mitapivat, pain crises, Pyrukynd, Rise Up trial

Agios; mitapivat; Pyrukynd; sickle cell disease; pain crises; clinical trial; Rise Up trial; hemoglobin response

US-Backed Group Reports Success with New Tuberculosis Treatment in Phase 2 Study

2 days ago talkbio0Tagged Clinical Trials, drug-resistant TB, linezolid, Phase 2 clinical trial, pretomanid, sorfequiline, SPaL, TB Alliance, Treatment Protocols, Tuberculosis, U.S., ultra-short regimen

tuberculosis; TB Alliance; Phase 2 clinical trial; sorfequiline; SPaL regimen; pretomanid; linezolid; drug-resistant TB; ultra-short regimen; US support; clinical trial results

Alkermes Ups Bid for Avadel Amid Lundbeck’s Competing Offer in Narcolepsy Drug Takeover Battle

2 days ago talkbio0Tagged Acquisition, Alkermes, Avadel Pharmaceuticals, bidding war, contingent value right, LUMRYZ, Lundbeck, M&A, Narcolepsy, Pharma, Primary Hypersomnia

Alkermes; Avadel Pharmaceuticals; Lundbeck; bidding war; Lumryz; narcolepsy; acquisition; contingent value right; pharma M&A; idiopathic hypersomnia

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