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Panel to Discuss Rebiotix BLA

[ Price : $8.95]

Federal Register notice: FDA announces a 9/22 Advisory Committee meeting to review a Rebiotix BLA for Rebyota (fecal microbiota, l...

Reata Faces FDA Efficacy Scrutiny on Omaveloxolone

[ Price : $8.95]

FDA raises efficacy concerns about Reata Pharmaceticals May-submitted NDA for omaveloxolone, indicated for treating patients with ...

Appeals Court Overturns Preemption-related Dismissal

[ Price : $8.95]

A federal appeals court overturns a district court decision to dismiss, due to federal preemption, product liability claims under ...

FDA Guide to Streamline Cancer Trial Eligibility Efforts

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A JAMA Oncology article discusses a collaboration between FDA, the National Cancer Institute, and patient and industry representat...

Enhertu Approved for HER2-low Breast Cancer

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FDA approves a Daiichi Sankyos Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable o...

Acadia Gets 2nd Complete Response on Alzheimer's Drug

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FDA issues Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treati...

Merck Refiling Gedapixant NDA Next Year

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Merck says it will file a response next year to an FDA complete response letter it received in January on an NDA for gefapixant an...

Delayed User Fee Reauthorization Will Hurt Recruitment: Woodcock

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Principal deputy commissioner Janet Woodcock says the user fee impasse on Capitol Hill will likely damage ongoing recruitment effo...

CDRH Wants Proposals on Device Learning Site Visits

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CDRH seeks proposals for medical device site visits as part of its Experiential Learning Program, which is intended to educate the...

Regenxbio to File BLA for Hunter Syndrome Treatment

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Regenxbio plans a BLA using the accelerated approval pathway for its RGX-121 Hunter Syndrome treatment.