2025 – Page 121

Metsera Advances with Positive Phase IIa Results for Monthly GLP-1RA Dosing

7 months ago talkbio0Tagged Clinical Trials, dosing, GLP-1RA, MET-097i, Metsera, monthly, Obesity

Metsera, GLP-1RA, MET-097i, obesity treatment, monthly dosing, weight loss, clinical trials

Capsida and AbbVie’s Gene Therapy Collaboration Yields Promising Results for Eye Diseases

7 months ago talkbio0Tagged AbbVie, Capsida Biotherapeutics, Dependovirus, gene therapy, genetic medicines, Ophthalmology specialty, strategic collaboration

Capsida Biotherapeutics, AbbVie, gene therapy, eye diseases, strategic collaboration, adeno-associated virus (AAV) engineering platform, ophthalmology, genetic medicines.

FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025

7 months ago talkbio0Tagged Advice, Aortic Valve Insufficiency, Artificial Intelligence, Drug Approval, Drug Development, Medical Devices, regulatory decision-making, United States Food and Drug Administration

FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development

FDA Advisory Panels: Activity Levels Normalize After 2023 Surge

7 months ago talkbio0Tagged Advisory Committees, Advisory Panels, Meetings, regulatory, United States Food and Drug Administration

FDA advisory panels, adcomms, regulatory changes, advisory committee meetings

Denali Therapeutics’ ALS Drug DNL343 Fails to Meet Primary Efficacy Endpoints in Phase 2/3 HEALEY ALS Platform Trial

7 months ago talkbio0Tagged Agonist, Amyotrophic Lateral Sclerosis, Clinical trial failure, Denali, DNL343, Eukaryotic Initiation Factor-2B, HEALEY, Neurodegenerative Disorders

Denali Therapeutics, DNL343, ALS (Amyotrophic Lateral Sclerosis), HEALEY ALS Platform Trial, eIF2B agonist, Clinical trial failure, Neurodegenerative diseases