April 8, 2024
Notice to Industry: Bioresearch Monitoring Information System (BMIS) Data In order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for […]
April 8, 2024
The US Food and Drug Administration (FDA) has expanded the approval of fam-trastuzumab–deruxtecan-nxki (Enhertu; AstraZeneca and Daiichi Sankyo, Inc) to adults with unresectable or metastatic HER2-positive […]
April 8, 2024
Summary Company Announcement Date: July 20, 2020 FDA Publish Date: July 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]
April 8, 2024
Summary Company Announcement Date: June 28, 2022 FDA Publish Date: June 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect labeling Company Name: […]
April 8, 2024
The US Food and Drug Administration (FDA) has approved idecabtagene vicleucel (ide-cel) (Abecma, Bristol-Myers Squibb/2seventy bio) for adults with relapsed or refractory multiple myeloma after two […]
April 8, 2024
SAN DIEGO — Fewer than half of the cancer drugs approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway between 2013 and 2017 […]
April 8, 2024
The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. […]
April 8, 2024
The devices track will provide an overview and highlights of how to get a new medical device to market, discuss some best practices for ensuring that […]
April 8, 2024
The drugs track will address major advances and innovation across various aspects of the drug development spectrum. Content will provide updates and cutting-edge insight on novel […]
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