Accelerated – Talk Bio

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

1 week ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Pfizer-backed CellCentric Secures $120M for Myeloma Drug Trials

3 weeks ago talkbio0Tagged Accelerated, Approved, CellCentric, Clinical Trials, Inobrodib, Multiple Myeloma, oral drug, p300/CBP inhibitor, Pfizer, Series C

CellCentric; Pfizer; multiple myeloma; Series C funding; inobrodib; p300/CBP inhibitor; oral drug; clinical trials; phase 2/3; accelerated approval

AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

3 weeks ago talkbio0Tagged AbbVie, Accelerated, ADC, Approved, Emrelis, Malignant neoplasm of lung, MET protein, human, Non-Small Cell Lung Carcinoma, Protein Overexpression, Solid Neoplasm, Telisotuzumab, therapeutic autologous dendritic cells, United States Food and Drug Administration, vedotin-tllv

AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval

PTC crashes as win for Novartis-partnered Huntington’s drug fails to convince investors

1 month ago talkbio0Tagged Accelerated, Approved, factor IX, PTC518, United States Food and Drug Administration

factor IX, PTC518, Accelerated, Approved, United States Food and Drug Administration

FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill

1 month ago talkbio0Tagged Accelerated, Agencies, Artificial Intelligence, Califf, Contraceptives, Oral, Infrequent, RIFs, United States Food and Drug Administration, Unspecified Abortion

United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies

NVIDIA’s AI Innovations: Pioneering the Future of Artificial Intelligence

5 months ago talkbio0Tagged Accelerated, Aortic Valve Insufficiency, Computation (action), Generative AI, Health care facility, innovations, NVIDIA AI, Robotics

NVIDIA AI Innovations, Generative AI, Accelerated Computing, Robotics, AI in Healthcare, AI Foundation Models

2024 FDA Drug Approvals: A Year of Strategic Approvals and Long-Awaited Treatments

5 months ago talkbio0Tagged 2024, Accelerated, approvals, cancer treatments, disease therapies, United States Food and Drug Administration

FDA drug approvals 2024, novel drug approvals, accelerated approvals, cancer treatments, rare disease therapies

uniQure Secures FDA Agreement on Accelerated Approval Pathway for Huntington’s Disease Gene Therapy AMT-130

6 months ago talkbio0Tagged Accelerated, AMT-130, Approved, cUHDRS, gene therapy, Huntington 's disease, NEFL gene, NfL, Regenerative Medicine, RMAT, UniQure, United States Food and Drug Administration

uniQure, FDA, Accelerated Approval, Huntington’s Disease, Gene Therapy, AMT-130, cUHDRS, Neurofilament Light Chain (NfL), Regenerative Medicine Advanced Therapy (RMAT)