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Hyperfine MRI Image Reconstruction Cleared

[ Price : $8.95]

FDA clears a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonan...

Imaging Drug OKd for Ovarian Cancer Detection

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FDA approves an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian ...

Multiple Violations Found in Surgenex Inspection

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FDA warns Scottsdale, AZ-based Surgenex about CGMP and other violations in its production and distribution of cellular products fo...

FDA Reclassifying HIV Viral Load Tests

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Federal Register notice: FDA proposes to reclassify human immunodeficiency virus viral load monitoring tests from Class 3 to Class...

Info Collection Revision on INDs

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Federal Register notice: FDA seeks comments on an information collection revision entitled Investigational New Drug Applications ...

FDA Approves Takedas Livtencity

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FDA has approved Takedas Livtencity as the first approved treatment for adults and pediatric patients with post-transplant cytomeg...

Aadi Bioscience NDA for Fyarro Approved

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FDA approves an Aadi Bioscience NDA for Fyarro (sirolimus protein-bound particles for injectable suspension) for treating adult pa...

Pfizer Seeks Injunction Against Ex-Employee

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Pfizer asks a California federal court for an injunction against an ex-employee it says took confidential information and trade se...

FDA Partial Hold on Kura Leukemia Trial

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FDA places a partial clinical hold a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory ac...

Regulatory Review Period for Immunomedics Trodelvy

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics breast cancer ...