Regulatory Setback

Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

2 weeks ago talkbio0Tagged COVID19 (disease), flu/COVID-19, Moderna, Policy, Recommendation, Regulatory Setback, United States Food and Drug Administration, vaccine access, Vaccines

Moderna; COVID-19 vaccine; FDA policy; combination flu/COVID-19 shot; vaccine access; mRNA-1083; vaccine recommendations; regulatory setback

FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth

1 month ago talkbio0Tagged Cytokinetics, Deferred, Evaluation, Extension, Hypertrophic obstructive cardiomyopathy, Mitigation Strategy, oHCM, PDUFA, Regulatory Setback, REMS, Risk, United States Food and Drug Administration

Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback

Merck and Daiichi Sankyo’s ADC Pact Hits Regulatory Setback in FDA Rejection

11 months ago talkbio0Tagged Antibody-Drug Conjugates, Daiichi, Deruxtecan, HER3 protein, Merck, Non-Small Cell Lung Carcinoma, patritumab, Regulatory Setback, Rejection (Psychology), Sankyo, United States Food and Drug Administration

Merck, Daiichi Sankyo, Antibody-Drug Conjugate (ADC), Patritumab Deruxtecan, FDA Rejection, Regulatory Setback, HER3 Protein, Non-Small Cell Lung Cancer (NSCLC)