Pathologic Function – Page 6

FDA Grants Tentative Approval for YUTREPIA, a New Treatment for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

11 months ago talkbio0Tagged Associated with, Lung Diseases, Interstitial, PH-ILD, Pulmonary arterial hypertension, Pulmonary Hypertension, regulatory exclusivity, Tentative Approval, Tyvaso, United States Food and Drug Administration, United Therapeutics, YUTREPIA

YUTREPIA, treprostinil, pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), FDA tentative approval, regulatory exclusivity, United Therapeutics, Tyvaso

Merck Acquires Curon’s Bispecific Antibody in $1.3B Deal; Legend Biotech Evaluates Options Amid Probes; Amgen’s FDA Filing Reveals Missing Adverse Events

11 months ago talkbio0Tagged Adverse event, amgen, Antibodies, Bispecific, CAR-T, Carvykti, China, Curon Biopharmaceutical, Evaluation procedure, File (record), Legend Biotech, Merck, United States Food and Drug Administration

Merck, Curon Biopharmaceutical , Bispecific antibody, Legend Biotech, Amgen, FDA filing, Adverse events, China investigations, CAR-T therapy, Carvykti

FDA Approval of Amgen’s Imdelltra for Lung Cancer Amidst Challenges and Market Competition

12 months ago talkbio0Tagged Adverse event, amgen, Approved, bispecific T-cell, Curon, Imdelltra, Legend, Malignant neoplasm of lung, United States Food and Drug Administration

Amgen, Imdelltra, FDA approval, lung cancer, bispecific T-cell engager, adverse events, Merck, Curon, Legend Biotech

FDA Approves ARS’s Epinephrine Nasal Spray for Emergency Allergic Reactions

12 months ago talkbio0Tagged anaphylaxis, Approved, epinephrine, Epipen, Nasal Spray, needle-free alternative, SLURP1 gene, United States Food and Drug Administration

FDA approval, epinephrine nasal spray, ARS Pharmaceuticals, anaphylaxis treatment, needle-free alternative, EpiPen

Pfizer and Sangamo’s Gene Therapy Shows Superiority Over Prophylaxis in Hemophilia A Study

1 year ago talkbio0Tagged factor VIII, gene therapy, Giroctocogene fitelparvovec, Hemophilia A, Hemorrhage, Pfizer, prevention & control, Rating (action), Sangamo

Pfizer, Sangamo, gene therapy, hemophilia A, prophylaxis, giroctocogene fitelparvovec, bleeding rate, Factor VIII

Pfizer’s Hemophilia A Gene Therapy Candidate Achieves Phase 3 Success

1 year ago talkbio0Tagged Fitelparvovec, gene therapy, Giroctocogene, Hemophilia A, Hemorrhage, Pfizer, Phase 3 trial, Rating (action)

Pfizer, Hemophilia A, Gene Therapy, Phase 3 Trial, Giroctocogene Fitelparvovec, Bleeding Rate Reduction

uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease

1 year ago talkbio0Tagged AMT-130, cUHDRS, Disease Progression, gene therapy, Huntington 's disease, Huntington 's Disease Rating Scale, Identifier, neurofilament protein L, NfL, Phase I/II trials, Regenerative Medicine, RMAT, Unified - Type of Agreement, UniQure

uniQure, Huntington’s disease, AMT-130, gene therapy, Phase I/II trials, disease progression, neurofilament light protein (NfL), Unified Huntington’s Disease Rating Scale (cUHDRS), Regenerative Medicine Advanced Therapy (RMAT) designation

UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data

1 year ago talkbio0Tagged AMT-130, Clinical Trials, Composite, cUHDRS, Disease Progression, gene therapy, Huntington 's disease, Huntington 's Disease Rating Scale, Identifier, NEFL gene, Neurodegenerative Disorders, NfL, Phase, RMAT, Unified - Type of Agreement, UniQure, United States Food and Drug Administration

UniQure, Huntington’s disease, gene therapy, AMT-130, FDA, RMAT designation, Phase I/II clinical trials, neurodegenerative disorder, neurofilament light (NfL), disease progression, composite Unified Huntington’s Disease Rating Scale (cUHDRS).