New Drug Application

BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418

3 weeks ago talkbio0Tagged Acoramidis, Approved, BBP-418, Biological Markers, BridgeBio, commercial, disease drug, File (record), Infrequent, Limb-girdle muscular dystrophy type 2A, NDA, New Drug Application, Phase 3 success, Ribitol, United States Food and Drug Administration

BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy

FDA Publishes New Filing Checklists to Prevent Drug Submission Delays

4 weeks ago talkbio0Tagged Abbreviated New Drug Application, Complete Response Letters, drug application, filing checklist, New Drug Application, regulatory guidance, submission delays, United States Food and Drug Administration

FDA; filing checklist; drug application; submission delays; New Drug Application (NDA); Abbreviated New Drug Application (ANDA); Complete Response Letters; regulatory guidance

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

2 months ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

3 months ago talkbio0Tagged Clinical Trials, Evidence, Federal Appeals Court, Hetlioz, jet lag disorder, New Drug Application, regulatory law, sNDA, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence

Aldeyra hopes new data for dry-eye disease drug will satisfy FDA

7 months ago talkbio0Tagged Aldeyra, Approved, Clinical Trials, Dry Eye Syndromes, New Drug Application, reproxalap, United States Food and Drug Administration

United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application

FDA Issues Complete Response Letter to Astellas for IZERVAY Supplemental New Drug Application

12 months ago talkbio0Tagged Age related macular degeneration, Astellas, Complete, Geographic Atrophy, IZERVAY, New Drug Application, Response process, United States Food and Drug Administration

FDA, Astellas, IZERVAY, geographic atrophy, age-related macular degeneration, Complete Response Letter, supplemental New Drug Application

Biohaven Achieves Breakthrough in Spinocerebellar Ataxia Treatment with Positive Pivotal Study Results for Troriluzole

1 year ago talkbio0Tagged Ataxia, Spinocerebellar, Neurodegenerative Disorders, New Drug Application, Submission, Troriluzole, United States Food and Drug Administration

Biohaven, Troriluzole, Spinocerebellar Ataxia (SCA), Pivotal Study Results, Neurodegenerative Disease, FDA Submission, New Drug Application (NDA)

Biohaven Revives Troriluzole Hopes with Positive Update for Spinocerebellar Ataxia

1 year ago talkbio0Tagged Ataxia, Spinocerebellar, Clinical Trials, Infrequent, Neurodegenerative Disorders, New Drug Application, SCA, Troriluzole, United States Food and Drug Administration

Troriluzole, Spinocerebellar Ataxia (SCA), Biohaven Pharmaceuticals, Neurodegenerative Disorders, FDA New Drug Application (NDA), Clinical Trials, Rare Diseases