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FDA OKs Phase 3 Trial of Lumbar Cell Therapy

[ Price : $8.95]

FDA gives DiscGenics the go ahead for a Phase 3 clinical trial after agreeing to the clinical protocols and chemistry, manufacturi...

Orexo Complete Response on Naloxone NDA

[ Price : $8.95]

FDA gives Orexo AB a complete response letter on its NDA for OX124, a high-dose naloxone rescue medication for opioid overdose.

Extrapolating Partial Onset Seizure Drug Data

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FDA posts a guidance entitled Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Pa...

Lexeo Seeks Accelerated Approval for Cardiomyopathy Drug

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Lexeo Therapeutics says it will explore with FDA the potential to seek accelerated approval for LX2006 and its use in treating Fri...

Pharma Marketer Sentenced in Compounding Scheme

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A federal court sentences pharmaceutical marketer Quintan Cockerell to two years and five months in prison and orders him to pay o...

CDRH Announces Organizational Changes

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CDRH announces new organizational changes to help it meet commitments under the Medical Device User Fee Amendments reauthorization...

Baxter Recalls Life200 Ventilators

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Baxter recalls its Life200 Ventilator System due to the potential for battery failure involving its charging dongle.

Lonza Swiss Facility Gets FDA-483

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FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.

Gene Therapy Interactive Site Tours Program

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Federal Register notice: FDA announces the Cellular and Gene Therapies Interactive Site Tours Program that is intended to give CBE...

Fast Track Awarded to Leukemia Drug

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FDA grants Sumitomo Pharma America a fast track designation for DSP-5336 and its use in treating certain patients with relapsed or...