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Dizal NDA for Lung Cancer Drug

[ Price : $8.95]

Dizal Pharmaceutical submits an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer.

Neurotech Review Extension on Retinal Disease BLA

[ Price : $8.95]

FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangie...

Public Citizen Blasts Potential Drug Approval Change

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Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on subs...

FDA Ban on Phenylephrine in Nasal Decongestants

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Federal Register notice: FDA issues a proposed administrative order to remove orally administered phenylephrine in OTC nasal decon...

Poor Training Found in Lab Inspections

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FDA cites a lack of adequate training in FY 2023 Good Laboratory Practice inspection form FDA-483s.

FDA Approves J&J Varipulse Platform

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FDA approves the J&J Varipulse pulsed field ablation platform to treat atrial fibrillation.

Sarepta Scraps Next-Gen Duchenne Drug

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Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with...

Model-Informed Drug Development Comments

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Four stakeholders respond to an FDA request for comments on guidance development and engaging with stakeholders on model-informed ...

Electa Instrument Recalls Biopsy Needle Kits

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Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microsco...

How Soon Will Trump Nominate Next FDA Head?

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FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.