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Janssen, Novavax Report Positive Covid Vaccine Data

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Janssen and Novavax report positive data from Phase 3 clinical trials involving each of their investigational Covid-19 vaccines.

Biogen Alzheimers BLA Review Extended

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FDA extends by three months the review of a Biogen BLA for aducanumab, indicated for treating Alzheimers disease.

Medtronic PMA OKd for DiamondTemp Ablation

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FDA approves a Medtronic PMA for the DiamondTemp Ablation system for treating patients with recurrent, symptomatic paroxysmal atri...

Class 1 Recall of Penumbra Jet 7 Xtra Flex catheter

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FDA classifies as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal ...

FDA Clears Vertex IND for Diabetes Therapy

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FDA clears a Vertex Pharmaceuticals IND to proceed with a clinical trial for VX-880, an investigational cell therapy for treating ...

Ascentage Pharma Orphan Status for Follicular Lymphoma

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FDA grants Ascentage Pharma an orphan drug designation for its novel Bcl-2 inhibitor, APG-2575, for treating patients with follicu...

FY 2021 First Quarter OPDP Metrics Released

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The CDER Office of Prescription Drug Promotion releases performance metrics on three measures for the first quarter of the current...

Perspectums Liver Cancer Support Tool Cleared

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FDA clears a Perspectum 510(k) for Hepatica, a precision oncology decision support tool for liver cancer.

Passage Bio Cleared for Gene Therapy Trial

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FDA clears a Passage Bio IND application for PBFT02, an adeno-associated virus-delivery gene therapy that is being studied for tre...

29 Groups Oppose Woodcock Nomination Over Opioids

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Public Citizen and other advocacy groups voice strong opposition to the potential nomination of Janet Woodcock as FDA commissioner...