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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

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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

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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

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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

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

Guide to Characterize Combination Cancer Drugs

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FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.

Fast Track Status for Zenith NUT Cancer Drug

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FDA grants Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT ca...

Reviewers Question Otsuka PTSD Drug Efficacy

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FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTS...

Partial Hold on Kezars Zetomipzomib Lifted

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FDA lifts a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomip...

HHS Finalizes FDA Employee Terminations

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HHS notifies over 3,000 FDA employees that their employment has been officially terminated effective 7/14.