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Issues in MIT Institutional Review Board

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FDA warns the MIT IRB on using humans as experimental subjects about repeat violations of regulations.

FDA OKs Phase 3 Trial of Lumbar Cell Therapy

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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

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

Rare Pediatric Disease Status for Leukemia Drug

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FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treati...

Priority Voucher Used for Vyvgart Hytrulo sNDA

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Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyeli...

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.