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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Abarca Health and LucyRx plan to combine to build a larger independent PBM serving more than 9 million members. The post Abarca Health and LucyRx to Combine to Scale Independent PBM Model appeared first on MedCity News .
Monthly and quarterly metrics of the FDA Generic Drugs Program.
Source: National Institutes of Health - Related MedlinePlus Pages: Shingles
Digital Health Technologies (DHTs) for Drug Development
The CLOSURE-AF (Catheter-Based Left Atrial Appendage Closure in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding as Compared With Best Medical Therapy) trial found that, among patients with atrial fibrillation (AF) at high risk for both stroke and bleeding, catheter-based left atrial appendage occlusion...
The cuts come as Karl Storz plans to retire the Asensus brand and the Senhance robot as part of organizational changes.
Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.
New Survey: Nearly 40 Percent of Insulin Users Polled Pay More Than $150 Per Month mcarmody Mon, 06/22/2026 - 15:51 Press release New Survey: Nearly 40 Percent of Insulin Users Polled Pay More Than $150 Per Month ARLINGTON, Va. June 23, 2026 New polling released today by the American Diabetes Association ® (ADA) finds that among respondents who rely on insulin, 72% report paying more than $35 per month, and nearly 40% pay more than $150 monthly. Cost is a more pronounced problem among middle-class Americans with diabetes—44% of insulin-dependent individuals who make between $50,000 and $75,000…
Executives with Abbott, PercuSense and Biolinq spoke with MedTech Dive about what’s next with multi-analyte sensor technology.
The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application.
Department of Health and Social Care spending by electronic purchasing card solution (ePCS), over £500.
Information on Federal Regulations related to Phase 1 INDs
Find FDA procedures and policies related to Phase 1 IND submissions
Information on FDA's CMC regulatory flexibilities for Phase 1 INDs
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Find FDA Guidance Documents related to Phase 1 IND submissions
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Master Protocols for Drug and Biological Product Development
Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
J&J’s Abiomed and manufacturing partner Oscor warned of a bleeding risk from devices used to introduce catheters to the body.
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