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SN Bioscience Gets Fast Track for Lung Cancer

[ Price : $8.95]

FDA gives SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer.

Route 92 Medical Recalls Faulty Catheters

[ Price : $8.95]

Route 92 Medical recalls (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instan...

Breakthrough for Novartis Scemblix in Leukemia

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FDA grants Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed P...

Vyaire Recalls Exercise Test Component

[ Price : $8.95]

Vyaire Medical recalls (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the companys Vyn...

RAPT Unblinding Data in Trials on Clinical Hold

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RAPT Therapeutics closes and unblinds two Phase 2 trials of zelnecirnon following FDA clinical holds due to liver failure in one p...

BIO on Collecting Race, Ethnicity Data

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BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in clinical trials and studies.

Device Lawyers Urge SCOTUS to Hear Off-Label Appeal

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DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decision upholding the conviction of...

No More Opioid Enriched Enrollment Studies: Califf

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During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriche...

BLA Accepted for Subcutaneous Opdivo

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FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously appro...

FDA Defines Device Remanufacturing

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FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.