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FDA Sets Acceptable NITMA Level for Ritonavir Products

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FDA publishes a guidance setting an acceptable intake level for NITMA, a nitrosamine drug substance-related impurity, in products ...

Grifols Vistaseal Gets Expanded Use in Pediatrics

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FDA approves a Grifols BLA supplement for its plasma-protein based fibrin sealant Vistaseal for controlling surgical bleeding in p...

Abeona Refiles BLA for Gene Therapy

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Abeona Therapeutics resubmits a BLA for prademagene zamikeracel (pz-cel), a gene therapy for patients with recessive dystrophic ep...

GE Healthcare EVair Recall Actions No Longer Apply: FDA

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FDA says GE Healthcare has determined there is no risk of elevated levels of formaldehyde from using its EVair compressor and rest...

Protega Abuse-Deterrent Oxycodone Approved

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FDA approves Protega Pharmaceuticals Roxybond (oxycodone hydrochloride), an abuse-deterrent, immediate-release 10 mg tablet for ma...

Canadian Drug Imports Wont Help U.S.: Study

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A Canadian Health Policy Institute analysis says U.S. drug importation programs developed by state governments will not be able to...

Novartis Wins Expanded Approval for Scemblix

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FDA grants an accelerated approval to Novartis for its supplemental NDA for Scemblix (asciminib) for the drugs expanded use in tre...

Trump as President May Tap RFK for FDA Head

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Former president Donald Trump appears to be leaning toward elevating former presidential candidate and now supporter Robert F. Ken...

FDA Wont Require Qsymia CV Outcome Trial

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FDA says it no longer requires a cardiovascular outcome trial for Vivus Qsymia weight-loss pill.

Paragonix Kidney Preservation Transport Device Cleared

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FDA clears a Paragonix Technologies 510(k) for its transportable perfusion device KidneyVault and its use in kidney preservation.