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FDA Approves Budesonide Oral Suspension for Eosinophilic Esophagitis

Pharmacy Times

The FDA approval marks the first and only FDA-approved oral therapy for this patient population, and the drug is expected to be available by the end of February.

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STAT+: FDA warns medical device makers about rise in fabricated data

STAT

Triple-check your data or we’ll reject your device, the FDA warned. The goal of third-party testing is to ensure a device meets the FDA’s standards in a range of areas, including biocompatibility, sterility, and mechanical performance.

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FDA Requests Black Box Warning for Approved CAR-T Therapies Over Secondary Cancer Concern

Drug Topics

As per US law Section 505(o)(4), the manufacturers are required to make the requested changes, respond with a modified version of the requested changes for review, or respond with a rebuttal within 30 days of the FDA's ask.

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The FDA isn’t afraid to yank a disappointing drug

STAT

Damian here with a look at some renewed interest in a yesteryear biotech craze, news of an FDA flex, and a dive into the science of vaccinology.   Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Read the rest…

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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FDA says yes to Allecra, no to Venatorx UTI drugs

pharmaphorum

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.

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Minerva slumps as FDA finds fault with schizophrenia filing

pharmaphorum

FDA has turned down Minerva Neurosciences' marketing application for roluperidone as a treatment for the negative symptoms of schizophrenia

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