Organic Chemical – Page 4

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

4 weeks ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Roche’s Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial

4 weeks ago talkbio0Tagged Adjuvant Therapy, Disease-Free Survival, ER-positive, giredestrant, HER2-negative, Malignant neoplasm of breast, Oral SERD, Phase 3 trial, recurrence prevention, Roche (company)

Roche; oral SERD; giredestrant; Phase 3 trial; early breast cancer; ER-positive; HER2-negative; disease-free survival; adjuvant therapy; recurrence prevention

Nuvalent Shares Positive Phase 1/2 ALK Inhibitor Data Rivaling Pfizer’s Lorbrena in Lung Cancer

4 weeks ago talkbio0Tagged ALK Inhibitor, ALKOVE-1 trial, Clinical Trials, CNS activity, Frequency of Responses, Lorbrena, lorlatinib, neladalkib, Non-Small Cell Lung Carcinoma, Nuvalent, Phase 1/2 data, United States Food and Drug Administration

Nuvalent; neladalkib; ALK inhibitor; ALKOVE-1 trial; Phase 1/2 data; non-small cell lung cancer (NSCLC); lorlatinib; Lorbrena; FDA; clinical trial; objective response rate; CNS activity

Bayer’s Pharma Division Grows as Restructuring Drives Major Changes

1 month ago talkbio0Tagged Administration occupational activities, Bayer, DSO, Dynamic Shared Ownership, Kerendia, Neoplasms, Nubeqa, pharma division, restructuring, Sales growth, Xarelto

Bayer; pharma division; restructuring; job cuts; Dynamic Shared Ownership (DSO); sales growth; oncology; Kerendia; Nubeqa; Xarelto; management changes

FDA Moves to Remove Black Box Warnings from Menopausal Hormone Therapies

1 month ago talkbio0Tagged Black Box Warning, estrogens, Hormone replacement therapy, Hormone Therapy, labeling change, Menopausal symptom, Menopause, Progestins, United States Food and Drug Administration, women 's health

FDA; menopause; hormone therapy; black box warning; HRT; estrogen; progestogen; labeling change; women’s health; menopausal symptoms

From Weight Loss to Hair Loss: The Search for the Next Blockbuster – Recent Developments and News (2024-2025)

1 month ago talkbio0Tagged Alopecia, Androgenetic Alopecia, baldness cure, blockbuster drugs, Glucagon-Like Peptide 1, Investments, minoxidil, pattern hair loss, Pelage Pharmaceuticals, PP405, Veradermics, Weight-Loss Agents

weight loss drugs; GLP-1; hair loss treatments; Pelage Pharmaceuticals; Veradermics; blockbuster drugs; pattern hair loss; baldness cure; minoxidil; PP405; androgenetic alopecia; biotech investment

Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST)

1 month ago talkbio0Tagged bezuclastinib, Clinical Trials, Cogent Biosciences, Frequency of Responses, Gastrointestinal Stromal Tumors, NDA, Phase 3, Progression-Free Survival, Standard (qualifier), Stock Surge, Submission, sunitinib

Cogent Biosciences; bezuclastinib; sunitinib; GIST; Phase 3; progression-free survival; objective response rate; NDA submission; clinical trial; stock surge; standard of care

Amgen’s Repatha Reduces First-Time Cardiovascular Events by 25% in Major Clinical Trial

1 month ago talkbio0Tagged amgen, Cardiovascular event, Cholesterol Drug, Clinical Trials, evolocumab, LDL Cholesterol Lipoproteins, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, VESALIUS-CV

Amgen; Repatha; evolocumab; cholesterol drug; PCSK9 inhibitor; cardiovascular events; clinical trial; VESALIUS-CV; primary prevention; heart attack; LDL cholesterol

Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease

1 month ago talkbio0Tagged Antisense Oligonucleotides, curative potential, Hypertriglyceridemia, Ionis, Pancreatitis, Acute, Phase 3 Clinical Trials, RNA-targeted therapy, Severe (severity modifier), Submission, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy

FDA Extends Review Period for Rhythm Pharmaceuticals’ Imcivree (Setmelanotide) in Acquired Hypothalamic Obesity

1 month ago talkbio0Tagged Agonist, amendment, goal, Hypothalamic structure, Imcivree, MC4R protein, human, PDUFA, Phase 3 trial, review extension, Rhythm Pharmaceuticals, setmelanotide, United States Food and Drug Administration

Imcivree; Rhythm Pharmaceuticals; FDA; review extension; acquired hypothalamic obesity; setmelanotide; PDUFA goal date; Phase 3 trial; major amendment; MC4R agonist