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PDUFA 7 Reauthorization Manufacturing, Digital Health, CBER Meetings

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FDA releases summaries of PDUFA 7 reauthorization meetings for three joint FDA/industry groups.

Fast Track for Primary Mitochondrial Myopathies Drug

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FDA grants Reneo Pharmaceuticals a Fast Track designation for REN001 and its use in treating patients with primary mitochondrial m...

Pacira Gains Approval to Expand ExParels Use

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FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to includ...

PMA Safety/Effectiveness Summaries Available

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Federal Register notice: FDA posts a list PMAs, and associated safety and effectiveness summaries, that have been approved from 10...

AstraZeneca Scrutinized on Covid Vaccine Data

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A clinical trial data and safety monitoring board questions AstraZenecas data it presented in a press release about its Covid-19 v...

Oramed Starts Second Phase 3 Insulin Capsule Trial

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Oramed says it is recruiting patients for a second Phase 3 study of its investigational oral insulin capsule to treat Type 2 diabe...

Reject New Mexico Drug Import Proposal: Stakeholders

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Three major drug advocacy groups petition FDA not to authorize a drug importation program proposed by New Mexico.

Comments Reopened on Drug Supply Chain Pilot

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Federal Register notice: FDA reopens the comment period for a 10/28 notice entitled The Drug Supply Chain Security Act Pilot Proje...

Petition Asks FDA Jakafi Safety Labeling Actions

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A petition asks FDA to open a docket and solicit comments on possible Boxed Warnings for Jakafi and other JAK inhibitors.

Mercks Keytruda Approved for Esophageal Carcinoma

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FDA approves Mercks Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients wit...