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Smart Womens Choice Consent Decree

[ Price : $8.95]

FDA says the Arizona federal court has approved a permanent injunction against Smart Womens Choice and its CEO to prevent them fro...

IceCure Medical Appeals De Novo Denial

[ Price : $8.95]

Israels IceCure Medical says it is appealing an FDA denial of the companys de novo classification request for its ProSense cryoabl...

Ascendis Pharma Refiles NDA on TransCon PTH

[ Price : $8.95]

Ascendis Pharma resubmits an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.

QS Violations at Ming Fai Industrial

[ Price : $8.95]

FDA warns Chinas Ming Fai Industrial Co about QS violations in its production of ultrasound gel and probe cover products.

Insanitary Conditions at Indias Global Pharma

[ Price : $8.95]

A lengthy FDA Warning Letter details issues at Indias Global Pharma Healthcare that led to contaminated ophthalmic drugs.

Bayer Withdrawing Aliqopa After Failed Study

[ Price : $8.95]

Bayer withdraws its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least t...

Nonprescription Panel Renewed for 2 Years

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Federal Register notice: FDA renews the Nonprescription Drugs Advisory Committee for an additional two years.

Former BD Exec Petitions FDA on Mesh Products

[ Price : $8.95]

Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studi...

ODAC Looking at Long Delays in 2 Acrotech Trials

[ Price : $8.95]

FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer d...

Cardinal Health Recalls Infusion Pump Syringes

[ Price : $8.95]

Cardinal Health recalls its latest version (6/2023) of its Monoject syringes branded as Cardinal Health Monoject syringes because ...