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Redact CRLs for Unapproved Applications: Petition

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An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved appl...

Senate Democrats Target Trump Drug Pricing Deals

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Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms o...

FDA Denies Petition to Withdraw Approval of VenaSeal

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FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical devic...

FDA Expands Approval of Sanofis Tzield to Younger Children

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FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to dela...

Multiple Violations at Chinas Xiamen Kang

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FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or d...

New FDA AEMS Dashboard Needs Context, Transparency: Professors

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Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and ...

FDA Accepts Roche sBLA for Gazyva in Lupus

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FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.

Makary Support Vouchers for Psychedelic Therapies

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FDA commissioner Marty Makary tells Fox Business that the agency will deploy its new national priority voucher program to signific...

FDA Approves Mercks Idvynso for Treating HIV

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FDA approves Mercks Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.

Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava

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Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the companys push to revive its approval pr...