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Aadi Bioscience NDA for Fyarro Approved

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FDA approves an Aadi Bioscience NDA for Fyarro (sirolimus protein-bound particles for injectable suspension) for treating adult pa...

Pfizer Seeks Injunction Against Ex-Employee

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Pfizer asks a California federal court for an injunction against an ex-employee it says took confidential information and trade se...

FDA Partial Hold on Kura Leukemia Trial

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FDA places a partial clinical hold a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory ac...

Lledo Debarred Over Clinical Trial Wrongdoings

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Federal Register notice: FDA issues an order permanently debarring Maytee Lledo from providing services in any capacity to a perso...

Laparoscopic Power Morcellation Containment is Class 2

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Federal Register notice: FDA classifies the general laparoscopic power morcellation containment system into Class 2 (special contr...

Sagent Pharma Recalls Levetiracetam Over Sterility Concerns

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Sagent Pharmaceuticals recalls four lots of levetiracetam injection due to container closure integrity concerns.

FDA Regulated Recalls Surge: Sedgwick Index

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The Sedgwick Recall Index for the third quarter shows that both medical device and drug recalls surged.

FDA Extends Oelogel-S10 Review Date

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FDA extends for three months the PDUFA action date for Amryts NDA for Oleogel-S10 to treat cutaneous manifestations of junctional ...

LPAD Pathway Rarely Used: GAO Analysis

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The Government Accountability Office reports that the FDA limited population pathway for antibacterial and antifungal drugs has go...

FDA Working on Pediatric Renal Function Models

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CDER says its scientists are investigating how to improve pediatric dose selection by predicting drug clearance from renal functio...