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Janssen Stops Macitentan Phase 3 Study

[ Price : $8.95]

Janssen Pharmaceutical discontines, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chron...

CymaBay Therapeutics Plans NDA for Seladelpar

[ Price : $8.95]

CymaBay Therapeutics says it will seek FDA approval for seladelpar for treating adult patients with primary biliary cholangitis af...

2 Priority Review Vouchers Issued

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Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rar...

FDA Update on Bone Matrix TB Issue

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FDA says it is working with the CDC to investigate cases of TB associated with a bone matrix product.

3 Draft Guides on 510(k) Devices

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Federal Register notice: FDA releases three draft guidances that are intended to improve the predictability, consistency, and tran...

Panel to Discuss Sickle Cell Therapy

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Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex ...

3 New 510(k) Guidances

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FDA posts an update on changes being made to the 510(k) program through three draft guidances.

Positron Emission Tomography Meeting Set

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The FDA Office of New Drugs announces a two-day meeting on PET drug issues and concerns.

Rybrevant Hits Phase 3 Goals in Some Lung Cancers

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Janssen says its Rybrevant met its progression-free survival endpoint in the MARIPOSA-2 lung cancer trial.

FDA Denies ICAN Pertussis Labeling Petition

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FDA denies an ICAN petition asking for changes to labeling for acellular pertussis vaccines to say they do not prevent infection o...