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Antisense Oligonucleotides Guidance Analyzed

[ Price : $8.95]

Three Morgan Lewis attorneys analyze a recent FDA guidance on antisense oligonucleotide drugs for patients with severely debilitat...

CTTI Identifies Covid-19 Trial Best Practices

[ Price : $8.95]

The Clinical Trial Transformation Initiative spells out eight best practices for Covid-19 treatment trials.

Precision Spine Degenerative Disc Device Cleared

[ Price : $8.95]

FDA clears a Precision Spine 510(k) for its Dakota ACDF Standalone System for treating degenerative disc disease.

LA Times Op-Ed Backs Woodcock for FDA Head

[ Price : $8.95]

An LA Times op-ed endorses CDER director and current FDA acting commissioner Janet Woodcock as the agencys next leader.

Janssen Submits EUA for Covid Vaccine

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Janssen Biotech submits an emergency use authorization application for its single-dose Covid-19 vaccine candidate.

Appeals Court Backs Greer Labs Win in Whistleblower Case

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The 4th Circuit affirms summary judgment granted to Greer Laboratories in a whistleblower case involving custom allergenic extract...

OCE Highlights Efforts During Covid Year in 2020

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FDAs Oncology Center of Excellence 2020 annual report describes the work it performed on behalf of cancer patients during a Covid-...

B-Secur HeartKey Software Library Cleared

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FDA clears a B-Secur 510(k) for its HeartKey software library, which was developed to enable scalability of medical grade EKG/ECG ...

Increased Heart, Cancer Risks with Xeljanz: FDA

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FDA says initial safety trial results show a higher risk of serious heart events and cancer in patients taking Pfizers Xeljanz for...

Extradited Israeli Faces Sentencing on Drug Distribution

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A decade-old, FDA-investigated case involving the unlicensed wholesale distribution of prescription drugs by Israeli citizen Boaz ...