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FDA Amends Animal Drug Regs for Approvals

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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applica...

Moderna to Increase Available Doses per Vial

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FDA permits two Moderna Covid-19 revisions regarding the number of doses per vial available.

Allarity PMA for Dovitinib Companion Diagnostic

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Allarity Therapeutics files a PMA for DRP-Dovitinib, the company's validated companion diagnostic for Novartis dovitinib that is i...

Five Covid Learnings Will Continue After Emergency: FDA

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FDA acting commissioner Janet Woodcock identifies five key activities the agency experienced during the Covid-19 pandemic that wil...

Bristol-Myers Pays $75m Over Medicaid Rebates Case

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Bristol-Myers Squibb agrees to pay the U.S. Government and participating states a total of $75 million to resolve allegations that...

Review Period Set for Tpoxx Smallpox Drug

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Siga Technologies Tpoxx (te...

Cutivate Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Fougera Pharmaceuticals Cutivate (fluticasone propionate) ointment, 0.005%, was not w...

Novartis Serentil Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Novartis Serentil (mesoridazine besylate) tablets 10 mg, 25 mg, 50 mg, and 100 mg wer...

FDA Raises Infection Risk for Reprocessed Urological Endoscopes

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FDA calls attention to the risk of infections associated with reprocessed urological endoscopes.

J&J Has Hands Full With Troubled Vaccine Contractor

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Johnson & Johnson says it is sending quality and compliance experts to its contract manufacturer Emergent Biosolutions after 15 mi...