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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

[ Price : $8.95]

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

[ Price : $8.95]

BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in clinical trials and studies.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

[ Price : $8.95]

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

[ Price : $8.95]

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

BLA Accepted for Subcutaneous Opdivo

[ Price : $8.95]

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

Tandem Diabetes Recalls Pump Mobile App

[ Price : $8.95]

Tandem Diabetes Care recalls its t:connect mobile app (version 2.7) on the Apple iOS platform that is used with the companys t:sli...

Party Drug MDMA Goes to Panel for PTSD

[ Price : $8.95]

Federal Register notice: FDA announces a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Lykos Therapeutics ...

Marks OK with Some Gene Accelerated Approval Mistakes

[ Price : $8.95]

CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.

Latest Implied Preemption Case Reviewed

[ Price : $8.95]

Three Winston & Strawn attorneys say that by declining to hear an appeal, the Supreme Court has affirmed that some state law claim...