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Court OKs FDA Ozempic Drug Shortage Action

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A Texas federal judge rules FDA acted properly in removing Novo Nordisks Ozempic and Wegovy from its drug shortage list.

Gottlieb Believes CBER Will Probe Sarepta Approval

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Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sareptas approval of Duchenne muscular dystrophy gene therapy E...

FDA Webview Closed on Juneteenth (6/19)

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FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.

Multiple Violations at Reset Technology Corp.

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FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental device...

Elevidys Shipping Nixed After 2nd Liver‑Failure Death

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Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to nonR...

CGMP Issues at Indias Kenil Healthcare

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FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.

Pfizers Talzenna Gets Updated Label

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FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastati...

Commissioners National Priority Voucher Program

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FDA launches the Commissioners National Priority Vouchers to speed drug reviews for companies with products that are aligned with ...

Aldeyra Files NDA Resubmission for Dry Eye Drug

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Aldeyra Therapeutics resubmits an NDA for reproxalap to treat the signs and symptoms of dry eye disease.

Zhejiang Huahai Pharmaceutical CGMP Issues

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FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about CGMP violations in its production of finished drugs.