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16% Oncology Phase 2 Patients Get Drugs Later OKd

[ Price : $8.95]

Canadian researchers find that 16% of patients in Phase 2 oncology trials receive treatments that are later approved by FDA for th...

Abanza WasherCap Mini Fixation Device Cleared

[ Price : $8.95]

FDA clears an Abanza 510(k) for its WasherCap Mini fixation system for soft tissue repair, including meniscal root repair and ante...

Regeneron Refiles BLA for Follicular Lymphoma

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FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory follicular lymphoma.

Generic Mifepristone Maker Wants to Defend Suit

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GenBioPro, which manufactures FDA-approved generic mifepristone, says it wants to be added to the list of defendants in a suit see...

More FDA Cuts Coming Down the Road

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Fresh on the heels of staff disruptions caused by the termination of about 1,000 probationary employees, the Trump administration ...

OTC Shampoo Suit Preempted by FDA Monograph

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Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state cl...

Janssen Vaccines FDA-483

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FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, ...

Detailed Comments on Protocol Deviations Draft Guide

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Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.

Precigen BLA for Respiratory Papillomatosis Therapy

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FDA accepts for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy f...

Fertility Center of California HCT/P Deviations

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FDA warns San Diego, CA-based Fertility Center of California about deviations from regulations governing cells, tissues, and cellu...