https://www.aacr.org/blog/2023/04/07/fda-approvals-in-oncology-january-march-2023/
Cancer Research Catalyst is launching a new blog series that will present a quarterly review of the latest oncology approvals from the FDA.
fda approvalsamerican associationoncologyjanuarymarch
https://www.aacr.org/blog/2023/06/30/fda-approvals-in-oncology-april-june-2023/
FDA approvals in the second quarter included antibody-drug conjugates and a modified stem cell therapy based on umbilical cord blood.
fda approvalsamerican associationoncologyapriljune
https://www.openpr.com/news/3494828/small-lymphocytic-lymphoma-pipeline-fda-approvals-unmet
Press release - ABNewswire - Small lymphocytic lymphoma Pipeline, FDA Approvals, Unmet Needs, Preclinical and Discovery Stage Product, and Companies 2024...
small lymphocytic lymphomafda approvalspipelineunmet
https://www.goodrx.com/drugs/medication-basics/fda-real-world-evidence
Under the Cures Act, the FDA established the Real-World Evidence program to accelerate medication approvals. But what exactly counts as real-world evidence,...
real world evidencefdausesrwedrug
https://www.biospace.com/fda-proposes-framework-for-cell-and-gene-therapy-approvals
Noting that the U.S. Food and Drug Administration (FDA) expects more than 200 investigational new drug applications (INDs) by 2020 per year, many of them cell...
fdadevelopsguidelineshandleexpected
https://www.raps.org/news-and-articles/news-articles/2022/5/fda-explains-plans-to-bolster-cell-and-gene-therap
Wilson Bryan director of the US Food and Drug Administration@s Office of Tissues and Advanced Therapies (OTA) in the agency@s Center for Biologics Evaluation...
gene therapyfdaexplainsplansbolster
https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/premarket-approvals-pmas-and-humanitarian-device-exemptions-hdes
List of Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)
premarketapprovalspmashumanitariandevice
https://www.aacr.org/blog/2019/08/06/fda-approvals/
New drug approvals in the past two months provide new options for patients with several types of cancer. Learn more about these new treatments.
fda approvalscancer typesprovideadvancesseveral
https://www.bcg.com/publications/2025/united-states-fda-approvals-exceed-average-number-but-have-lower-sales-projections
2024 FDA approvals rose but with lower sales projections. Advances in AI and drug discovery fuel optimism, while competition, niche therapies, and pricing...
fda approvalslowersalesprojectionsbcg
https://futurism.com/neoscope/fda-ai-drugs-hallucinations
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug approvals.
fdausingaispeeddrug
https://www.raps.org/news-and-articles/news-articles/2025/11/asia-pacific-roundup-malaysia-accepts-fda-medtech
Malaysia@s Medical Device Authority (MDA) has welcomed a trade agreement with the US that has implications for medtech approvals.
asia pacificroundupmalaysiaacceptsfda
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-device-application-approvals
Listing of the 2023 Biological Device Application Approvals
biologicaldeviceapplicationapprovalsfda
https://www.devdiscourse.com/article/health/3087294-fda-approvals-fraud-settlements-and-global-health-initiatives-latest-health-news
This health news brief covers significant updates including the FDA's approval of new therapies for multiple sclerosis and eczema, Walgreens' settlement of a...
global health initiativesfda approvalsfraudsettlementslatest
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-verzenio-abemaciclib-adjuvant-treatment-adult-patients-hormone
FDA approvals of Verzenio (abemaciclib) for adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive,...
fdacbursteditionapprovals
https://www.ajmc.com/view/foundation-medicine-notches-additional-fda-approvals
The FDA has approved new indications for Foundation Medicine's liquid biopsy assay and also its tissue-based companion diagnostic for solid tumors.
foundation medicinefda approvalsnotchesadditionalajmc
https://www.raps.org/news-and-articles/news-articles/2021/4/FDA-adcomm-declines-yanking-accelerated-approvals
At the halfway mark in its review of six @dangling@ accelerated approvals for cancer immunotherapies, an advisory committee to the US Food and Drug...
cancer immunotherapiesfdadeclinesyankaccelerated
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2024-biological-device-application-approvals
Listing of 2024 Biological Device Application Approvals
biologicaldeviceapplicationapprovalsfda
https://www.plasticsengineering.org/2025/06/fda-accepts-recycled-ldpe-for-food-002485/
Jun 16, 2025 - The U.S. Food and Drug Administration is approving more food-contact packaging materials that incorporate post-consumer recycled plastics.
recycled plasticsfood packagingfdaapprovals