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Class 2 for Automated Glycemic Controllers

[ Price : $8.95]

Federal Register notice: FDA classifies the interoperable automated glycemic controller into medical device Class 2 (special contr...

FDA Releases 5-page Form 483 to Leesar Inc.

[ Price : $8.95]

FDA releases a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facil...

Allogene Fast Track for Renal Cell Carcinoma Drug

[ Price : $8.95]

Allogene Therapeutics receives an FDA fast track designation for its allogeneic CAR T product (ALLO-316) for treating patients wit...

Warning on ACON Biotech Covid Tests

[ Price : $8.95]

FDA issues a warning against using ACON Biotech Covid-19 tests due to false results concerns.

Venatorx Pharma Plans NDA for Infection Fighter

[ Price : $8.95]

Venatorx Pharmaceuticals plans a fourth quarter NDA submission following positive results from its pivotal Phase 3 study evaluatin...

FDA Sets PDUFA Target Date for Acadia Nuplazid sNDA

[ Price : $8.95]

FDA says it will act on 8/4 on an Acadia Pharmaceuticals resubmitted sNDA for Nuplazid to treat hallucinations and delusions assoc...

Judge Approves StemGenex Client Settlement

[ Price : $8.95]

A California federal judge approves a $3.65 million settlement between the defunct StemGenex stem cell clinic and 1,063 former cli...

Look Into PBM Competitive Concerns: Grassley

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Sen. Charles Grassley calls on the Federal Trade Commission to overcome a deadlocked vote and initiate a study into the business p...

Draft Guide on Drug Supplier Verification Systems

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Federal Register notice: FDA makes available a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Se...

Zydus/Cadila Gets FDA-483 After Inspection

[ Price : $8.95]

FDA issued Zydus Lifesciences (formerly known as Cadila Healthcare) a three-item Form FDA-483 after recently inspecting the firms ...