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FDA Wants to Stem Common Chronic Diseases: Califf

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FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.

Smith+Nephew New Hip System Cleared

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FDA clears a Smith+Nephew 510(k) for its new Catalystem Primary Hip System.

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.

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...

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...