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FDA Hits Rentschler Biopharma with 9-item 483

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A February inspection at Rentschler Biopharmas German drug substance manufacturing plant results in a nine-item FDA-483 that cites...

Health Canada OKs ALS Drug Delayed at FDA

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While FDA extends its own NDA review, Health Canada approves Amylyx Pharmaceuticals Albrioza (sodium phenylbutyrate and ursodoxico...

Ekso Bionics Exoskeleton Cleared for Multiple Sclerosis

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FDA clears an Ekso Bionics Holdings 510(k) to market its EksoNR robotic exoskeleton for use with multiple sclerosis patients.

Homology Clinical Hold on Gene Therapy Lifted

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FDA removes a clinical hold on Homology Medicines and its pheNIX gene therapy clinical trial evaluating HMI-102 in adults with phe...

Lillys Olumiant Approved for Alopecia

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FDA approves an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia ar...

FDA Updates Woodside Acquisitions Covid Tests Recall

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FDA updates a Class 1 recall notice involving Woodside Acquisitions Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio S...

Info Collection on Dietary Supplement Notifications

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Federal Register notice: FDA sends to OMB an information collection extension entitled Food Labeling: Notification Procedures for ...

Info Collection on Tropical Disease Vouchers

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Federal Register notice: FDA submits to OMB an information collection extension entitled Tropical Disease Priority Review Vouchers...

GSK Positive Data from Respiratory Virus Vaccine Trial

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GSK announces positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the companys...

FDA Inspection at Bioberica Nets 5-item 483

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An FDA January inspection at Bioiberica (Barcelona, Spain) leads to a five-item Form FDA-483 that cited significant GMP violations...