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Organon/Shanghai Henlius Seek Biosimilar Approval

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FDA accepts for review a Shanghai Henlius Biotech and Organon BLA for their biosimilar of Amgens Prolia/Xgeva (denosumab).

CGMP Violations at Turkeys MedOffice Saglik

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FDA warns Turkeys MedOffice Saglik Endustri Anonim Sirketi about CGMP violations in its manufacturing of finished drugs.

8 Observations in Novo Nordisk FDA-483

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FDA releases a form FDA-483 with eight observations from an inspection at a Novo Nordisk drug substance manufacturing facility in ...

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...