What FDA’s Drugs@FDA Data Files Change — And What They Don’t
The FDA’s Drugs@FDA Data Files package makes approval data more accessible. Here’s what is actually available now, and how much it is likely to matter.
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FDA
Articles currently tagged FDA.
FDA Probes Rare Neurologic Complications Tied to Common Anesthetic
U.S. regulators are examining reports of catastrophic brain injury and death after sevoflurane anesthesia in patients with suspected genetic risk.
How the FDA’s Competitive Generic Therapy Pathway Shapes Drug Access
The FDA’s Competitive Generic Therapy pathway targets drugs with little or no competition. Here’s how it works, who benefits, and what remains uncertain.
FDA Clears Enhertu for Two Uses in Early HER2-Positive Breast Cancer
Regulators grant dual approvals for fam-trastuzumab deruxtecan-nxki in adults with early-stage HER2-positive breast cancer, expanding treatment options.
FDA Clears Two New Uses for T-DXd in Early HER2-Positive Breast Cancer
The FDA has approved two indications for trastuzumab deruxtecan in early HER2-positive breast cancer. Here is what that means and what remains uncertain.
What the FDA’s Drugs@FDA Data Files Reveal—and What Comes Next
The FDA’s Drugs@FDA Data Files open a structured window into approved drugs. Here’s what the new ZIP, data definitions, and ERD actually change.
What the FDA’s Drugs@FDA Data Files Reveal—and What They Don’t Yet Settle
The FDA’s Drugs@FDA Data Files offer a structured view of drug approvals. Here is what is now available, and why firm conclusions should wait for more evidence.
What the FDA’s Expanded Selumetinib Approval Means for Young NF1 Patients
The FDA has extended selumetinib’s use to NF1 patients as young as 1. Here is what is confirmed, what is still thinly documented, and why timing matters.