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Biohaven NDA Filed for Spinocerebellar Ataxia Drug

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FDA accepts for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia.

Breakthrough Status for Knee Arthritis Device

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FDA grants Guerbet a Breakthrough Device Designation for LipioJoint, a liquid embolic agent designed to alleviate pain in patients...

SpringWorks Gomekli Approved for Neurofibromatosis

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FDA approves a SpringWorks Therapeutics NDA for Gomekli (mirdametinib) for treating certain patients with neurofibromatosis Type 1...

Regeneron BLA Resubmitted for Multiple Myeloma

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FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/re...

Change FDA AI Policies: Gottlieb

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Former FDA commissioner Scott Gottlieb says the agency should revert to clinical decision support system regulatory policies appro...

CA Man Sentenced Over Unapproved Drugs

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FDA says Jeremy Brown of Simi Valley, CA has been sentenced for introducing unapproved drugs into interstate commerce.

Sentec/Percussionaire Breathing Circuit Recalled

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Sentec/Percussionaire recalls its Phasitron breathing circuit kits after receiving a complaint that the venturi component of the k...

Pliant Pauses Bexotegrast Trial for Safety Review

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Pliant Therapeutics pauses enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of ...

Guide on IRB Written Procedures

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FDA posts a final guidance entitled Institutional Review Board (IRB) Written Procedures that is intended to harmonize FDA and HHS ...

Boehringer Ingelheim Plans NDA for Lung Disease

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Boehringer Ingelheim plans to submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following its release of...