United States Food and Drug Administration – Page 4

Genmab CEO on the $8B Acquisition of Merus: Strategy Behind the ‘Very Fair’ Deal and Plans to Polish a Rough Diamond

3 weeks ago talkbio0Tagged Acquisition, Antibodies, Bispecific, Breakthrough Therapy, Cancer of Neck, CEO, expansion, Genmab, Head, Merus, Neoplasms, Perspective, Petosemtamab, pipeline, United States Food and Drug Administration

Genmab; Merus; petosemtamab; acquisition; oncology; head and neck cancer; bispecific antibody; FDA Breakthrough Therapy; pipeline expansion; biotech; $8B deal; CEO perspective

Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe

3 weeks ago talkbio0Tagged Biological Factors, Biosimilars, CDMO, Contract agreement, Digital innovation, Europe, Gdańsk, Guanosine Monophosphate, Manufacturing, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Rezon Bio, United States Food and Drug Administration, Warsaw-Duchnice

Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA

New Confirmatory Study Suggests Progress in Applied Therapeutics–FDA Alignment for Rare Disease Drug

3 weeks ago talkbio0Tagged Apply, Clinical Trials, CMT-SORD, confirmatory study, Govorestat, Infrequent, regulatory alignment, United States Food and Drug Administration

Applied Therapeutics; govorestat; CMT-SORD; rare disease; FDA; confirmatory study; clinical trial; regulatory alignment

Eli Lilly’s Oral SERD Inluriyo Approved by FDA for ESR1-Mutated Breast Cancer

3 weeks ago talkbio0Tagged Approved, Carcinoma breast stage IV, Eli, Eli Lilly, EMBER-3 trial, ESR1 gene, Estrogen receptor positive, HER2-negative, Imlunestrant, Inluriyo, Mutation, Oral SERD, United States Food and Drug Administration

Eli Lilly; Inluriyo; oral SERD; imlunestrant; FDA approval; ESR1 mutation; metastatic breast cancer; estrogen receptor positive; HER2-negative; EMBER-3 trial

uniQure’s Gene Therapy AMT-130 Significantly Slows Huntington’s Progression in Pivotal Trial

4 weeks ago talkbio0Tagged AMT-130, Approved, Clinical Trials, Disease Progression, gene therapy, huntingtin-lowering, Huntington 's disease, Nerve Degeneration, UniQure, United States Food and Drug Administration

Gene therapy; uniQure; AMT-130; Huntington’s disease; clinical trial; disease progression; FDA approval; huntingtin-lowering; neurodegeneration

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

4 weeks 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

FDA’s Move to Update GSK’s Leucovorin for Autism Raises Questions on Dose, Supply, and Data

4 weeks ago talkbio0Tagged Autistic Disorder, Clinical Data, Dosage, drug relabeling, leucovorin, Neurodegeneration Due To Cerebral Folate Transport Deficiency, SmithKline Beecham, United States Food and Drug Administration, Wellcovorin

FDA; GSK; leucovorin; Wellcovorin; autism; cerebral folate deficiency; drug relabeling; dose; supply; clinical data

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

4 weeks ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing