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J&J Seeks Approval for Oral Peptide for Psoriasis

[ Price : $8.95]

Johnson & Johnson files an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque ...

Industry Vet and Academic Tidmarsh Named CDER Head

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FDA names Stanford pediatrics adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director.

Integra Recalls MicroMyst Applicators

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Integra LifeSciences recalls (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilizat...

Sarepta Disregards FDA Request to Stop Shipping Elevidys

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Sarepta brushes off an informal request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene t...

Roche Reports Mixed Data on COPD Studies

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Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clini...

Guide on Biosimilar Formal Meeting Requsts

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FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

SunMed Manual Resuscitators Recalled

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SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.

Sen. Durbin Calls for Crackdown on DTC Telehealth

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Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platform...

ICH Guide on Including Pregnant Women in Trials

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FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women i...

FDA Rejects Genentechs Bid to Expand Columvi Use

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FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.