May 2025
Novo eyes fourth-quarter FDA verdict for oral Wegovy filing
Obesity, Novo, United States Food and Drug Administration, Decision, Oral cavity, Wegovy, semaglutide, Overweight
Exclusive: Vertex drops AAV gene therapy research, tRNA therapy partnership
gene therapy, Dependovirus, Transfer RNA, Partnership, Industry, research, Safety
ElevAAte and the push for East Asian American leaders in biopharma
ElevAAte, biopharma, East Asian American, Leadership, leaders, Asian Americans, Mentorships, East Asian Americans, Ken Song
Cigna’s Evernorth unveils 2 new programs aimed at GLP-1s
Programs – Publication Format, Glucagon-Like Peptide 1, Cigna ‘s, GLP-1s, Pharmacy facility, Enhance (action), Pharmaceutical Services
FDA frees Amgen’s phase 1 obesity asset from clinical trial hold
Obesity, United States Food and Drug Administration, Amgen, MariTide, Study on Hold, Participant
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
Exact Sciences plans ‘transformative year’ with 3 cancer test debuts
Science, MRD, Exact brand biomedical or dental material, Hypersensitivity
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
United States Food and Drug Administration, Allogeneic bone graft, Mycobacterium tuberculosis, guidances, Disease Outbreaks, standards characteristics