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Sagent Pharma Recalls Phenylephrine HCl Injection

[ Price : $8.95]

Sagent Pharmaceuticals recalls three lots of phenylephrine hydrochloride injection, USP (10 mg/mL) due to sterility concerns.

Qardio ECG Monitor/Capture Device Cleared

[ Price : $8.95]

FDA clears a Qardio 510(k) for its QardioCore ambulatory electrocardiogram device for holter monitoring applications, including it...

OPDP Cites Misleading Nurtec ODT Video

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion cautions Biohaven Pharmaceuticals that a video interview for its Nurtec ODT contain...

Six Former FDA Heads Urge Biden to Pick Commissioner

[ Price : $8.95]

Six former FDA commissioners urge President Biden to prioritize the nomination and confirmation of an FDA commissioner.

Idorsia NDA for Insomnia Drug

[ Price : $8.95]

FDA begins reviewing an Idorsia NDA for its investigational daridorexant for treating adult patients with insomnia.

Former FDA Lawyer Heading TSG Medical Device Practice

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TSG Consulting hires former FDA lawyer Laurie Clarke to lead its medical device regulatory practice.

Pfizer Vaccine Plant Has Troubled Compliance History: Report

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Kaiser Health News reports that the Pfizer McPherson, KS, sterile drug facility that is slated to start producing Covid-19 vaccine...

Vertex Gets Fast Track for Diabetes Cell Therapy

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FDA grants Vertex Pharmaceuticals a fast track designation for VX-880 for treating patients who have Type 1 diabetes with severe h...

Bryant Ranch Recalls Mislabeled Spironolactone

[ Price : $8.95]

Bryant Ranch Prepack recalls four lots of spironolactone tablets after determining they have been mislabeled and display the incor...

Lannett Incorporating FDA Biosimilar Insulin Product Feedback

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Lannett says it is incorporating FDA recommendations into a pivotal trial for its biosimilar insulin glargine product that is unde...