Gene or Genome – Page 2

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

Exclusive: Charles Fuchs departs Roche to become Chief Medical Officer at Tubulis, steering ADC pipeline after $401M Series C

3 weeks ago talkbio0Tagged Antibody-Drug Conjugates, Cambridge office, Charles Fuchs, Chief Medical Officer, genentech, Hematology (discipline), NaPi2b, Neoplasms, pipeline, Roche (company), Series C financing, Solid Neoplasm, therapeutic autologous dendritic cells, TPBG gene, TUB-030, TUB-040, Tubulis

Charles Fuchs; Tubulis; Roche; Genentech; chief medical officer; antibody-drug conjugates; ADC pipeline; TUB-040; TUB-030; Series C financing; oncology; hematology; solid tumors; NaPi2b; 5T4; Cambridge office

FDA Memo Claims COVID Vaccine Linked to 10 Child Deaths, Faces Expert Skepticism and Criticism

3 weeks ago talkbio0Tagged COVID, Death of child, MEMO1 gene, United States Food and Drug Administration, Vaccine Safety, Vaccines, VAERS, Vinay Prasad

FDA memo; COVID vaccine; child deaths; Vinay Prasad; VAERS; vaccine safety

Amgen Acquires Oxford Spinout Dark Blue Therapeutics for Up to $840 Million, Gaining Preclinical Cancer Drug

3 weeks ago talkbio0Tagged Acquisition, Acute lymphocytic leukemia, amgen, AML, CSNK1E gene, Dark Blue Therapeutics, Leukemia, Myelocytic, Acute, Oxford spinout, protein degrader

Amgen; Dark Blue Therapeutics; acquisition; Oxford spinout; DBT 3757; AML; ALL; protein degrader

Vaccine Investors Stay Silent Amid Trump Administration’s Childhood Vaccine Schedule Cuts

3 weeks ago talkbio0Tagged Centers for Disease Control and Prevention (U.S.), Childhood Vaccines, Recommendation, RFK gene, Trump vaccine schedule, vaccine overhaul

Trump vaccine schedule; RFK Jr.; CDC recommendations; childhood vaccines; vaccine overhaul

AbbVie Partners with China’s Zelgen on DLL3-Targeted T-Cell Engager ZG006 in Up-to-$1.2B Deal

3 weeks ago talkbio0Tagged AbbVie, Alveltamig, DLL3 gene, Small cell carcinoma of lung, T-Cell engager, Zelgen, ZG006

AbbVie; Zelgen; ZG006; Alveltamig; DLL3; T-cell engager; small cell lung cancer; licensing deal

GSK strikes RNA-based neuro and kidney disease collaboration with CAMP4 Therapeutics

1 month ago talkbio0Tagged Antisense Oligonucleotides, Antistreptolysin O, CAMP4, Collaboration, gene upregulation, Kidney Diseases, LRPAP1 gene, milestone payments, Neurodegenerative Disorders, Platform, regulatory RNA, RNA therapeutics, royalties, SmithKline Beecham

GSK; CAMP4 Therapeutics; RNA therapeutics; regulatory RNA; antisense oligonucleotides; ASO; RAP Platform; neurodegenerative diseases; kidney disease; renal disease; gene upregulation; biotech collaboration; licensing deal; milestone payments; tiered royalties

FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations

1 month ago talkbio0Tagged Cautionary Warning, COVID19 (disease), Marty Makary, mRNA Vaccines, Myocarditis, RFK gene, Safety, United States Food and Drug Administration, vaccine deaths, Vaccines

Marty Makary; FDA; COVID-19 vaccine; myocarditis; vaccine deaths; safety warnings; RFK Jr.; mRNA vaccines