September 26, 2024
Share on PinterestIs FluMist, the at-home nasal vaccine that was recently approved by the FDA, as effective at preventing illness as traditional flu shots? Michael Buckner/Getty […]
September 25, 2024
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
September 25, 2024
Employing MRI-targeted biopsy instead of systematic biopsy reduces overdiagnosis of low-grade prostate cancer by more than half, although diagnoses may be delayed among a small minority […]
September 25, 2024
(Reuters) – Hello Health Rounds Readers! Today we report on new genetic research that may lead to tools or treatments to prevent cholera outbreaks, and on […]
September 25, 2024
On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung […]
September 25, 2024
The current legislative authority for BsUFA, authorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) will expire in September 2017. The […]
September 25, 2024
Drug Sponsor Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir – Xeglyze HATCHTECH PTY LTD Medical (PDF – 4 MB) Addendum (PDF […]
September 25, 2024
Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. The Center for Drug Evaluation […]
September 25, 2024
FDA provides information to assist industry in the development of generic drugs and submission of abbreviated new drug applications (ANDAs). This section includes links to summary […]
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