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Boehringer Scraps Covid Therapy Due to Lack of Benefit

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Boehringer Ingelheim discontinues a Phase 2 trial of a first-in-class compound for reducing the risk or severity of acute respirat...

FDA Covid Lessons Learned

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FDA acting commissioner Janet Woodcock discusses two lessons learned about clinical research from the Covid-19 pandemic.

FDA Extends Review Date for Kadmons Belumosudil

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FDA extends the PDUFA review date for Kadmons belumosudil for three months to review additional information submitted by the compa...

Info Collection on Prescription Drug Marketing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Marketing 21 CFR Pa...

Origin Biosciences Wins Priority Review Voucher

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Federal Register notice: FDA issues a priority review voucher to Origin Biosciences after it gained approval for a qualified rare ...

Aveo Oncology Renal Cell Carcinoma Drug OKd

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FDA approves an Aveo Oncology NDA for Fotivda (tivozanib) for treating adults with relapsed or refractory advanced renal cell carc...

Panel to Review Continued Approval of 6 Drug Indications

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FDA announces a three-day Oncologic Drugs Advisory Committee meeting to discuss the continued approval of six indications associat...

FDA Releases Revised Triumeq, Dovato Labels

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FDA releases revisions to four sections of labeling for ViiVs Triumeq and Dovato.

FDA Supports 21st Century Manufacturing Technologies: Article

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A Parenteral Drug Association article explores how FDA is supporting advanced drug manufacturing techniques.

Reuters Details Lilly Whistleblower Allegations

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Reuters details the story of a Lilly human resources officer at the firms Branchburg, NJ, facility who claims company officials ig...