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Expanded Use of Prograf Relied on RWE

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FDA approves a new use for Astellas Pharmas Prograf (tacrolimus), based on real-world, for use in combination with other immunosup...

Shift to Include Pregnant Women in Trials: FDA

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FDA pushes for a major paradigm shift to move the clinical development community from systemic exclusion to the inclusion of pregn...

Aortic Aneurysm Device is Breakthrough

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FDA grants Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascu...

Ardelyx Tenapanor NDA Hits FDA Snag

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Ardelyx says FDA found deficiencies in the NDA review for tenapanor that preclude discussion of labeling and post-marketing requir...

Nevro OKd for Treating Diabetic Neuropathy

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FDA approves a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy.

Latest Federal Register Notices

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FDA Review posts the Federal Regiter notices for the week ending 7/16/2021.

Pfizer Covid Vaccine BLA Decision Due 1/2022

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FDA grants Pfizer/BioNTech a priority review (user fee action due 1/2022) for a BLA for their mRNA vaccine to prevent Covid-19 in ...

KorvaLabs Covid Test EUA Revoked

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KorvaLabs requests that its emergency use authorization for the Curative SARS-Cov-2 (Covid-19) test be revoked because it is now u...

Dexcom 510(k) on 3rd Party Programming Interface

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FDA clears a Dexcom 510(k) for its Dexcom Partner Web application programming interface to enable invited third-party developers t...

Kadmon Pharmas Rezurock Approved by FDA

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FDA approves a Kadmon Pharmaceuticals NDA for Rezurock (belumosudil), a kinase inhibitor for treating certain adult and pediatric ...