Disease or Syndrome – Page 12

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

1 month 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

Roche’s Top Three Ambition in Obesity Not Dependent on a Single Megablockbuster

1 month ago talkbio0Tagged cardiometabolic care, Diagnostics, digital health, Ecosystem, Obesity, Portfolio diversification, Roche (company), Weight-Loss Agents

Roche; obesity strategy; ecosystem approach; pharmaceuticals; diagnostics; digital health; cardiometabolic care; portfolio diversification; weight-loss drugs

FDA Rejects Scholar Rock’s SMA Drug Due to Catalent Indiana Manufacturing Issues

1 month ago talkbio0Tagged apitegromab, Catalent Indiana, Complete, Drug Approval, manufacturing issues, Response Letter, Scholar Rock, SMA, Spinal Muscular Atrophy, United States Food and Drug Administration

FDA; Scholar Rock; Apitegromab; SMA; Spinal Muscular Atrophy; Catalent Indiana; Complete Response Letter; Manufacturing issues; Drug approval

Bristol Myers Squibb to Launch Schizophrenia Drug Cobenfy in UK at US Price

1 month ago talkbio0Tagged Antipsychotic Agents, Cholinergic Receptors, Cobenfy, drug price, launch, Myers, Nance-Horan syndrome, Prices, Schizophrenia, squibb, U.S., UK

Bristol Myers Squibb; Cobenfy; schizophrenia; UK launch; drug pricing; US list price; NHS; cholinergic receptors; antipsychotic; 2026

Pfizer Acquires Metsera to Compete with Zepbound in Obesity Market

1 month ago talkbio0Tagged Acquisition, Amylin, Clinical Trials, dosing, Glucagon-Like Peptide 1, MET-097i, MET-233i, Metsera, mimetics, monthly, Obesity, Pfizer, Zepbound

Pfizer; Metsera; obesity treatment; Zepbound; GLP-1 therapies; MET-233i; monthly dosing; amylin mimetic; MET-097i; acquisition; clinical trials

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

1 month ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation

FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

1 month ago talkbio0Tagged BTK inhibitor, Clinical action, December 2025, drug review, Multiple Sclerosis, nrSPMS, PDUFA, sanofi, Tolebrutinib, United States Food and Drug Administration

FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA

AstraZeneca and SOPHiA GENETICS Expand AI-Powered Cancer Testing Collaboration

1 month ago talkbio0Tagged Artificial Intelligence, AstraZeneca, cancer testing, High-Throughput Nucleotide Sequencing, Malignant neoplasm of breast, Malignant neoplasm of prostate, PIK3CA/AKT1/PTEN pathway, Precision Medicine, real-world evidence, SOPHiA GENETICS

AstraZeneca; SOPHiA GENETICS; AI; cancer testing; breast cancer; prostate cancer; next generation sequencing (NGS); PIK3CA/AKT1/PTEN pathway; real-world evidence; precision medicine