Organic Chemical – Page 5

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

1 month ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

1 month ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

1 month ago talkbio0Tagged Approved, Bio, IBTROZI, Malignant neoplasm of lung, Nuvation, Oral treatment, Protein-tyrosine kinase inhibitor, ROS1-positive NSCLC, taletrectinib, United States Food and Drug Administration

Nuvation Bio; FDA approval; Ibtrozi; taletrectinib; lung cancer; ROS1-positive NSCLC; oral treatment; tyrosine kinase inhibitor

Novo Nordisk Signs $812M Deal with Deep Apple to Develop Non-Incretin Obesity Drugs

2 months ago talkbio0Tagged cardiometabolic disease, Deep Apple, Drug Discovery, G-Protein-Coupled Receptors, Non-Incretin, Nordisk, Obesity, research collaboration, Small Molecule

Novo Nordisk; Deep Apple Therapeutics; obesity; non-incretin; GPCR; cardiometabolic disease; small molecules; research collaboration; deal; drug discovery

FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns

2 months ago talkbio0Tagged Biktarvy, CD4 + T-cell, Clinical Trials, Gilead Sciences, GS-1720, GS-4182, HIV, Lenacapavir, Lymphocyte Count measurement, safety signal, Study on Hold, United States Food and Drug Administration

FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir

Axsome Plots New Fibromyalgia Trial After FDA Refuses Review of Former Pfizer Candidate

2 months ago talkbio0Tagged Analgesics, AXS-14, Axsome, Clinical Trials, esreboxetine, Fibromyalgia, File (record), Pfizer, refusal, trial design, United States Food and Drug Administration

Axsome Therapeutics; esreboxetine; fibromyalgia; FDA; refusal to file; clinical trial; Pfizer; AXS-14; trial design; pain medicine

NewAmsterdam Reports Cholesterol Drug Obicetrapib May Slow Alzheimer’s Biomarker Buildup

2 months ago talkbio0Tagged Alzheimer 's disease, Apolipoprotein E4, Biological Markers, CETP, cholesterol ester transfer protein inhibitor, NewAmsterdam Pharma, Obicetrapib, p-tau217, Phase 3

NewAmsterdam Pharma; obicetrapib; cholesterol ester transfer protein inhibitor (CETP); Alzheimer’s disease biomarkers; p-tau217; ApoE4; BROADWAY trial; Phase 3

Merck’s Oral PCSK9 Inhibitor Enlicitide Significantly Reduces LDL Cholesterol in Phase 3 Trials

2 months ago talkbio0Tagged Administration of prophylactic statin, cholesterol, CORALreef, CORALreef AddOn, enlicitide, HeFH, Hypercholesterolemia, Familial, Hyperlipidemia, LDL-C, Merck, Oral Therapy, PCSK9 inhibitor

Merck; PCSK9 inhibitor; enlicitide; phase 3 trials; cholesterol; LDL-C; oral therapy; hyperlipidemia; familial hypercholesterolemia; CORALreef HeFH; CORALreef AddOn; statin therapy

AstraZeneca’s Calquence Combo Approved for First-Line CLL in EU

2 months ago talkbio0Tagged Amplify trial, Approved, AstraZeneca, BTK inhibitor, Calquence, Chronic Lymphocytic Leukemia, EU, First line treatment, obinutuzumab, venetoclax

AstraZeneca; Calquence; EU approval; chronic lymphocytic leukaemia; first-line treatment; venetoclax; obinutuzumab; BTK inhibitor; Amplify trial

Regenxbio Reports Consistent One-Year Benefit for DMD Gene Therapy RGX-202

2 months ago talkbio0Tagged AFFINITY DUCHENNE trial, Biological Markers, Clinical Trials, Functional, gene therapy, Muscular Dystrophy, Duchenne, Phase III, Regenxbio, SLC6A8 Inhibitor RGX-202

Regenxbio; DMD; Duchenne muscular dystrophy; RGX-202; gene therapy; AFFINITY DUCHENNE trial; clinical trial; microdystrophin; biomarker; phase I/II; functional data