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Clinical Hold Issues Outlined for Cholesterol Gene Therapy

[ Price : $8.95]

FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was plac...

FDA Confirms Survival Rate With Abiomeds Heart Device

[ Price : $8.95]

FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approv...

ANDA Pre-Submission Facility Correspondence Guidance

[ Price : $8.95]

FDA posts a draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions....

Getinge Intra-Aortic Balloon Pumps on Shortage Lis

[ Price : $8.95]

FDA adds Getinge Maquet/Datascope Intra-Aortic Balloon Pump devices to its device shortage list.

Draft Guide on Bioequivalence Statistical Approaches

[ Price : $8.95]

FDA releases a draft guidance entitled Statistical Approaches to Establishing Bioequivalence that is intended to provide recommend...

Oncologic Drugs Committee Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond th...

NECC Co-owner Sentenced to 1 Year Jail Term

[ Price : $8.95]

A Boston federal judge sentences former co-owner of now-closed New England Compounding Center, Gregory Conigliaro, to one year in ...

Biden Signs Medical Marijuana/Cannabidiol Research Law

[ Price : $8.95]

President Biden signs into law HR 8454, the Medical Marijuana and Cannabidiol Research Expansion Act.

FDA Rejects Y-mAbs BLA for Brain Condition

[ Price : $8.95]

FDA sends Y-mAbs Therapeutics a complete response letter on its BLA for I-omburtamab and its use in treating CNS/leptomeningeal me...

FDA Lifts Hold on Leukemia/Lymphoma Therapy

[ Price : $8.95]

FDA lifts a clinical hold against Beam Therapeutics and its BEAM-201 for treating relapsed/refractory T-cell acute lymphoblastic l...