Temporal Concept – Page 3

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

3 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

3 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

Jazz and Zymeworks Bispecific Antibody Zanidatamab Delivers Practice-Changing Results in Stomach Cancer Study

4 weeks ago talkbio0Tagged Antibodies, Bispecific, erbB-2 Receptor, gastroesophageal adenocarcinoma, Jazz, Malignant neoplasm of stomach, orphan drug designation, Overall Survival, Pharmacotherapy, Phase 2 trial, Phase 3, practice-changing, Progression-Free Survival, Zanidatamab, Zymeworks

Jazz Pharmaceuticals; Zymeworks; zanidatamab; bispecific antibody; HER2; gastroesophageal adenocarcinoma; stomach cancer; phase 2 trial; phase 3 HERIZON-GEA-01; overall survival; progression-free survival; chemotherapy; practice-changing; Orphan Drug designation

Navigating JPM 2026: Biotech/Biopharma Trends, Policy Impacts, and Forward Outlook

4 weeks ago talkbio0Tagged Biopharma, dealmaking, Drug Discovery, financing strategy, Health Policy, innovation, JPM, trends qualifier

JPM 2026; biotech trends; biopharma trends; healthcare policy; AI in drug discovery; financing strategy; dealmaking; innovation

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

Merck Again Brings Out Big Bucks, Buys Cidara in $9.2B Antiviral Push

4 weeks ago talkbio0Tagged Acquisition, Antiviral Agents, Breakthrough Therapy, CD388, Cidara Therapeutics, Influenza, J&J, Merck, Phase 3, sanofi, United States Food and Drug Administration

Merck; Cidara Therapeutics; CD388; antiviral; acquisition; influenza; phase 3; FDA Breakthrough Therapy; J&J; Sanofi; Keytruda

FDA Unveils ‘Plausible Mechanism Pathway’ to Accelerate Personalized Therapies, Inspired by Baby KJ

4 weeks ago talkbio0Tagged Baby KJ, Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, Infrequent, mechanism pathway, personalized therapies, regulatory innovation, United States Food and Drug Administration

FDA; personalized therapies; gene editing; plausible mechanism pathway; Baby KJ; rare diseases; CRISPR; regulatory innovation

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA Plan, Launching Its Hyper-Precise Aortic Care Platform

4 weeks ago talkbio0Tagged AiORTA, Anatomical segmentation, Aortic Aneurysm, automated aortic surgery, Clearance, Clinical, cloud-based healthcare, hyper-precise aortic care, Infantile Neuroaxonal Dystrophy, measurement automation, Medical service, Preoperative, United States Food and Drug Administration, vascular AI, ViTAA, workflow improvement

ViTAA Medical; FDA 510(k) clearance; AiORTA Plan; hyper-precise aortic care; automated aortic surgery planning; vascular AI; preoperative measurement automation; cloud-based healthcare; aortic aneurysm segmentation; clinical workflow improvement

Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

1 month ago talkbio0Tagged bezuclastinib, Cogent Biosciences, Effectiveness, Frequency of Responses, Gastrointestinal Stromal Tumors, Infrequent, Malignant neoplasm of stomach, Progression-Free Survival, second-line treatment, Submission, United States Food and Drug Administration

Cogent Biosciences; bezuclastinib; unprecedented efficacy; rare stomach cancer; gastrointestinal stromal tumor (GIST); FDA submission; second-line treatment; objective response rate; progression-free survival

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