Letter [Publication Type] – Talk Bio

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FDA Issues Untitled Letter to NJ Drugmaker for Misleading Cancer Drug Claims at Conference

2 months ago2 months ago talkbio0Tagged Antineoplastic Agents, booth, Edenbridge, Letter [Publication Type], Promotion (action), United States Food and Drug Administration

FDA, untitled letter, misleading promotion, exhibit booth, cancer drug, Edenbridge Pharmaceuticals

Sanofi Assures No Supply Disruptions Following FDA Warning Letter for US Manufacturing Site

3 months ago talkbio0Tagged Cautionary Warning, Cyclic GMP, deviations, interruptions, Letter [Publication Type], manufacturing site, sanofi, U.S., United States Food and Drug Administration

Sanofi, FDA warning letter, US manufacturing site, supply interruptions, CGMP deviations

Moderna CEO Reflects on 2024 Challenges and Advances in Shareholder Letter

4 months ago talkbio0Tagged 2024, COVID19 (disease), Letter [Publication Type], Moderna, mRNA medicines, Respiratory syncytial virus, Review [Publication Type], shareholder, Stéphane Bancel, Vaccines

Moderna, shareholder letter, 2024 review, RSV vaccine, COVID-19 vaccine, mRNA medicines, Stéphane Bancel

FDA Issues Warning Letter to Indian CDMO Brassica for Data Falsification and Poor Hygiene Practices

9 months ago talkbio0Tagged Asian Indian, Cautionary Warning, CDMO, Cyclic GMP, Data Falsification, Indian, Letter [Publication Type], Pharma, United States Food and Drug Administration, Violations

FDA, Warning Letter, Brassica Pharma, Data Falsification, Poor Hygiene, Indian CDMO, CGMP Violations