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The accelerated approval lets patients with HER2-mutant non-small cell lung cancer take sevabertinib right away, without needing to try chemotherapy first.
Hospital pharmacists and industry are jointly pushing to extend medicine barcodes down to the individual dose — a change they say could sharply cut bedside medication errors.
Three lots of the hospital multi-dose vials are being pulled nationwide after reports of leaking, cracked containers and particulate contamination that could be life-threatening if injected.
With two suppliers shutting down, the FDA is deploying regulatory tools to prevent a shortage of the intravenous nutrition that premature and critically ill babies depend on.
Camizestrant is the first cancer therapy cleared based on spotting a resistance mutation in circulating tumor DNA — letting doctors switch treatment before scans show the cancer is growing again.
Ionis’s Zanvastro, an antisense drug that dials down a toxic protein, stabilized walking in patients with the ultra-rare, progressive neurological disorder — which until now had no disease-modifying therapy.