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Relmada Depression Trial Shows Promise

[ Price : $8.95]

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

Taysha Discontinues Gene Therapy Program

[ Price : $8.95]

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

UCB Faces Another Review Delay on Bimekizumab

[ Price : $8.95]

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

Menopauses Impact on Clinical Pharmacology Workshop

[ Price : $8.95]

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

FDA Recalls Saline Solution

[ Price : $8.95]

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

Gene Therapy Stakeholder Info Request

[ Price : $8.95]

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

CGMP, Other Violations at PureChemPros

[ Price : $8.95]

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

FDA Information Technology Plan

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

Breakthrough for Parkinsons Neurostimulator

[ Price : $8.95]

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

Drug Use-Related Software Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related...