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GSK Plans for Antibiotic NDA in 2nd Half

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GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase...

26 FDA Orphan Drug Approvals in 2024

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CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals ...

RFK Jr. Attacks Corrupt Drug Firms and DTC Ads

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In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault against the pharmaceutical industry ...

Sen. Durbin Queries FDA on Drug Promo Staff Cuts

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Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regul...

Promising Trial Results for Wegovy Add-on: Veru

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Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semagl...

Mitsubishi Tanabe Resubmits NDA for Parkinsons Combo

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FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous ...

Zhejiang Huahai FDA-483 Released

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FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.

To Make FDA Great Again, Impeach RFK Jr.

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To make FDA great again, FDA Webview editor James G. Dickinson urges Congress to impeach HHS secretary RFK Jr. on four counts of m...

Inspection Issue at AACE Pharmaceuticals

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FDA warns Fairfield, NJ-based AACE Pharmaceuticals about the lack of an adequate quality control unit for its drug manufacturing f...

Quality System Issues in Spains Sedecal Inspection

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FDA warns Madrid, Spain-based Sedecal about Quality System violations in its production of mobile digital radiography systems.