United States Food and Drug Administration

FDA places partial clinical hold on Merck and Daiichi Sankyo’s I-DXd lung cancer trial after interstitial lung disease deaths

20 hours ago talkbio0Tagged Antibody-Drug Conjugates, Clinical Trials, Daiichi, Deruxtecan, grade 5 ILD, I-DXd, IDeate-Lung02, ifinatamab, Lung Diseases, Interstitial, Merck, Partial, Sankyo, Small cell carcinoma of lung, United States Food and Drug Administration

FDA partial clinical hold; ifinatamab deruxtecan; I-DXd; IDeate-Lung02; Merck; Daiichi Sankyo; small cell lung cancer; interstitial lung disease; grade 5 ILD; antibody-drug conjugate; clinical trial deaths

Recent Biotech News: Altimmune’s Pemvidutide Advances in MASH, Emerging China Obesity Players, and Ipsen Phase 2 Setback

22 hours ago talkbio0Tagged Altimmune, China, Failed, IMPACT trial, Ipsen, MASH, Obesity, pemvidutide, Phase 2, United States Food and Drug Administration

Altimmune; pemvidutide; MASH; Phase 2b; IMPACT trial; FDA; China obesity; Ipsen; Phase 2 fail

Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study

2 days ago talkbio0Tagged Approved, Clinical Trials, Eli, Glucagon-Like Peptide 1, injectable incretins, national priority review voucher, Obesity, Oral cavity, orforglipron, Phase 3 trial, United States Food and Drug Administration, Wegovy, weight maintenance, Zepbound

Eli Lilly; orforglipron; oral GLP-1; FDA approval; national priority review voucher; ATTAIN-MAINTAIN trial; obesity treatment; weight maintenance; Zepbound; Wegovy; injectable incretins; Phase 3 trial

Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations

2 days ago talkbio0Tagged compounding pharmacy, East Windsor facility, Empower Pharmacy, Facility (object), Glucagon-Like Peptide 1, Inspection (procedure), layoffs, manufacturing shutdown, New Jersey operations, Outsourcing, Qualitative form, United States Food and Drug Administration, Workforce reduction

Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction

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

3 days 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

GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)

3 days ago talkbio0Tagged Approved, Asthma, biology (field), Depemokimab, dosing, eosinophilic, Exdensur, IL-5 Inhibitor, Phenotype, Severe (severity modifier), SmithKline Beecham, twice-yearly, type 2 inflammation, ultra-long acting, United States Food and Drug Administration

GSK; Exdensur; depemokimab; FDA approval; severe asthma; ultra-long-acting biologic; twice-yearly dosing; type 2 inflammation; eosinophilic phenotype; IL-5 inhibitor

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

4 days ago talkbio0Tagged AR navigation, augmented, Clearance, Cranial Navigation platform, cranial neurosurgery, External Ventricular Drain, ICU bedside procedures, intraoperative guidance, Medivis, neurosurgery innovation, Spine Navigation, surgical intelligence, United States Food and Drug Administration

Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation