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EUA for Novavax Covid-19 Vaccine

[ Price : $8.95]

Federal Register notice: FDA announces an Emergency Use Authorization issued 7/13 to Novavax, Inc. for its Novavax Covid19 Vaccine...

Device Cybersecurity Firm Hires Former FDA Reviewer

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Medical device cybersecurity consulting firm MedCrypt hires former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Sch...

FDA Clears BrainsWay Device for Depression

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FDA clears a BrainsWay 510(k) for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and dep...

Florida Sues FDA Over Drug Importation Plan

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The state of Florida files a lawsuit against FDA for failing to timely respond to a state-sought Freedom of Information Act reques...

2 Draft Guides on Drug Analytical Procedures

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Federal Register notice: FDA posts two draft guidances entitled Q2(R2) Validation of Analytical Procedures and Q14 Analytical Proc...

bluebird bio Wins Priority Voucher

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Federal Register notice: FDA issues bluebird bio a priority review voucher for obtaining approval of Zynteglo (betibeglogene autot...

BMS, Janssen Moving Stroke Drug to Phase 3

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After reporting Phase 2 data, Bristol Myers Squibb and Janssen Pharmaceuticals say they are planning to begin a Phase 3 trial of t...

Alert on Respironics Airway Pressure Devices

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FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a...

Erytech Scraps Plans for Leukemia BLA

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Erytech Pharma says it is no longer planning to submit a BLA for Graspa in hypersensitive acute lymphoblastic leukemia following F...

Farxiga Phase 3 Data Show Mortality Benefit

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New Phase 3 data on AstraZeneca's Farxiga (dapagliflozin) demonstrate a mortality benefit compared to placebo in patients with hea...