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FDA Delays Iterum Antibiotic NDA Review

[ Price : $8.95]

FDA tells Iterum Therapeutics that it needs more time to review company-submitted materials related to the ongoing NDA review for ...

Activ Surgical Interoperative Imager Cleared

[ Price : $8.95]

FDA clears an Activ Surgical 510(k) for the ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

J&J Juggling Several Covid Vaccine Issues

[ Price : $8.95]

Georgia, North Carolina, Iowa and Colorado health officials report adverse reactions observed at vaccination sites after administe...

Info Collection on FDA Recall Regulations

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.

CBER Safety Report Specifications Updated

[ Price : $8.95]

Federal Register notice: CBER makes available version 2.2 of the Specifications for Preparing and Submitting Postmarket Individual...

Ex-FDAer Laughren Joins BetterLife Pharma

[ Price : $8.95]

Retired FDA psychiatry products director Thomas Laughren joines BetterLife Pharma as a regulatory advisor.

BMS Reports Positive Opdivo Results in CheckMate-648 Trial

[ Price : $8.95]

Bristol Myers Squibb announces positive topline results from the CheckMate-648 Phase 3 Opdivo trial in some esophageal cancers.

Gilead Gets Full Approval for Breast Cancer Drug

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FDA grants Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for certain adult patients with unresectable lo...

FDA Posts Inspection Form From Emergent Bio

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FDA posts a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions Baltimo...

Fiscal Year Biological Product Deviation Report Summary

[ Price : $8.95]

CBER publishes its annual fiscal year summary of biological product and HCT/P deviation reports.