Accelerated – Page 2

Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

3 months ago talkbio0Tagged Accelerated, Advanced Melanoma, Approved, Cancer Therapeutic Procedure, Complete, IGNYTE trial, nivolumab, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration, vusolimogene oderparepvec

Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

3 months ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

4 months ago talkbio0Tagged Accelerated, Biopharma, CNPV, Drug Approval, national priorities, Priority Review, public health medicine (field), Review [Publication Type], United States Food and Drug Administration, unmet

FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs

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

5 months 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

5 months 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

5 months 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

6 months 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

6 months 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