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Multiple Violations at WAVi Co.

[ Price : $8.95]

FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unappr...

Stakeholders Views on FRAME

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FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.

Clinical Hold Lifted on Mersanas XMT-2056

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FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynth...

Sage Huntingtons Drug Gets Orphan Status

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FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.

Regulatory Review Period for Omegaven

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (f...

Changes Sought to FDAs IT Strategy

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Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.

FDA Should Develop Vision PRO Tool: AdvaMed

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The Advanced Medical Technology Association urges FDA to proceed with stakeholder recommendations to develop a central patient-rep...

FDA Warns on 26 Eye Drop Products

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FDA issues a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could re...

Sarepta Seeking Gene Therapy Expanded Use

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Sarepta Therapeutics says it will file a supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to expand the therapys ...

GSK Jemperli Trial Meets Endpoint

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GSK says a Phase 3 trial evaluating its Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial ca...