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Advisors Back Ardelyx Kidney Disease Drug

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Members of the FDA Cardiovascular and Renal Drugs Advisory Committee vote to recommend approval of Ardelyx tenapanor for a kidney ...

Pfizer/BioNTech Studying Next Gen Covid Vaccine

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Pfizer and BioNTech begin a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to enhance SARS-CoV-...

Pazdur Puts Foot Down on Single Country Trials

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FDA Oncology Center of Excellence director Richard Pazdur says data from multiregional trials that represent the major Internation...

FDA Planning White Oak Return Under Hybrid Approach

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FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur endorse a return of FDA employees to the ...

Class 1 Recall on Omnipod Insulin Delivery System

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An Insulet recall of its Omnipod DASH Insulin Management System receives a Class 1 recall classification by FDA.

More Draft ANDA Bioequivalence Guides Available

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for use by ANDA sponsor...

FDA Cybersecurity Modernization Action Plan

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Two FDA information technology executives describe the agencys new cybersecurity modernization action plan.

FDA Preliminary Assessment on OTC Naloxone

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Federal Register notice: FDA announces its preliminary assessment that certain types of naloxone hydrochloride drug products may b...

Put Aduhelm Approval on Hold: Researchers

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Academic medical center researchers worldwide call on FDA to pause its approval of Biogens Aduhelm to treat Alzheimers disease whi...

CA Appeals Court Upholds Federal Preemption

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Attorney Steven Boranian praises a California Court of Appeal decision invoking federal preemption in a failure-to-warn case invol...