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Alert on B.Braun Microbore Extension Sets

[ Price : $8.95]

FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed f...

J&Js Bladder Cancer NDA Gets Priority Review

[ Price : $8.95]

FDA grants priority review to Johnson & Johnsons NDA for TAR-200 for treating patients with Bacillus Calmette-Gurin-unresponsive h...

pCR May Not be Valid Rectal Cancer Endpoint: Study

[ Price : $8.95]

A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments ...

FDA Looking to Expand Project Orbis Outside Oncology

[ Price : $8.95]

FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding...

Caranx AI Valve Replacement Software Cleared

[ Price : $8.95]

FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operativ...

Sandoz Recalls Mislabeled Cefazolin for Injection

[ Price : $8.95]

Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer compla...

FDA Warns Firm Marketing Blood Pressure Estimator

[ Price : $8.95]

FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despit...

Anselamimab Trial Misses Primary Endpoint in Amyloidosis

[ Price : $8.95]

A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows...

New Orphan Product Grant Funding Opportunity

[ Price : $8.95]

FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.

7 Observations in Natco Pharma FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.