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Sandoz BLA Filed for Tysabri Biosimilar

[ Price : $8.95]

FDA accepts for review a Sandoz BLA for what the company describes as the first biosimilar copy of Biogens Tysabri (natalizumab), ...

Draft Guide on Real-time Oncology Reviews

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FDA posts a draft guidance entitled Real-Time Oncology Review (RTOR) that discusses the program and its promotion of earlier submi...

Priority Review for Enhertu sBLA in HER2 Low Breast Cancer

[ Price : $8.95]

FDA accepts for priority review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) fo...

Expanding Use of Remote Regulatory Assessments: Guide

[ Price : $8.95]

FDA releases a draft guidance on the expanded use of remote regulatory assessments beyond the Covid-19 pandemic to assess an FDA-r...

3 NDAs Withdrawn Over Annual Reports

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Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file require...

Regulatory Review Period for Lillys Tauvid

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys Tauvid (flortauc...

Real-time Oncology Review Draft Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Real-Time Oncology Review (RTOR) that provides recommendati...

Cavazzoni Sees ctDNA Endpoint as Promising

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CDER director Patrizia Cavazzoni tells Friends of Cancer Research that the potential use of circulating tumor DNA as an endpoint t...

Failure to Respond to ANDA Complete Response Letters: Guide

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FDA releases a final guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.

FDA Posts Q & A Guide on Orange Book

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FDA posts a final guidance entitled Orange Book Questions and Answers that answers commonly asked questions it has received from i...