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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

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

CRL for ARS Pharmaceuticals Neffy

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FDA issues a complete response letter to an ARS Pharmaceuticals NDA for neffy, calling for a repeat-dose study.

Kimera Labs Illegally Marketing Exosomes: FDA

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FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP ...

CDRH International Harmonization Plan

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FDA publishes a draft CDRH strategic plan for medical device international harmonization.

More 510(k) Changes Likely: Attorneys

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Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to...

Guide on Drug Substantial Evidence

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Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...