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Human Drugs

FDA Approves Takedas Livtencity

FDA has approved Takedas Livtencity as the first approved treatment for adults and pediatric patients with post-transplant cytomegalovirus infection t...

Human Drugs

Aadi Bioscience NDA for Fyarro Approved

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

Pfizer Seeks Injunction Against Ex-Employee

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

Human Drugs

FDA Partial Hold on Kura Leukemia Trial

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

Federal Register

Lledo Debarred Over Clinical Trial Wrongdoings

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

Federal Register

Laparoscopic Power Morcellation Containment is Class 2

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

Human Drugs

Sagent Pharma Recalls Levetiracetam Over Sterility Concerns

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

FDA Regulated Recalls Surge: Sedgwick Index

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

Human Drugs

FDA Extends Oelogel-S10 Review Date

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

Human Drugs

LPAD Pathway Rarely Used: GAO Analysis

The Government Accountability Office reports that the FDA limited population pathway for antibacterial and antifungal drugs has gotten little use sinc...