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Human Drugs

Relmada Depression Trial Shows Promise

Relmada Therapeutics says a Phase 3 trial in Major Depressive Disorder shows that patients treated daily with REL-1017 for up to one year experienced ...

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Biologics

Taysha Discontinues Gene Therapy Program

Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axonal neuropathy after r...

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Human Drugs

UCB Faces Another Review Delay on Bimekizumab

UCB says its BLA for plaque psoriasis drug bimekizumab is facing another FDA review extension.

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Federal Register

Menopauses Impact on Clinical Pharmacology Workshop

Federal Register notice: FDAs Office of Womens Health and Office of Clinical Pharmacology announces a 10/11 public workshop: Menopause: Potential Impa...

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Medical Devices

FDA Recalls Saline Solution

Medline Industries recalls its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility concerns.

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Federal Register

Gene Therapy Stakeholder Info Request

Federal Register notice: CBER requests information from stakeholders about critical scientific challenges and opportunities to advance individualized ...

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Human Drugs

CGMP, Other Violations at PureChemPros

FDA warns Tempe, AZ-based PureChemPros it is illegally manufacturing and distributing unapproved and misbranded new drugs that violate CGMP regulation...

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Federal Register

FDA Information Technology Plan

Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.

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Medical Devices

Breakthrough for Parkinsons Neurostimulator

FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive thera...

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Federal Register

Drug Use-Related Software Guide

Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.