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FDA Denies Petition Seeking to Block Liquidia NDA

[ Price : $8.95]

FDA rejects a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for...

Guard Medical Gets Clearance for NPseal

[ Price : $8.95]

FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with ...

At-Home Test Authorized for Syphilis

[ Price : $8.95]

FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.

Catheter Separation Devices are Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies intravenous catheter force-activated separation devices into Class 2 (special controls).

Febrile Illness Detection Devices are Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify selected microbial agents th...

iRhythm Hit with 483 After July Inspection

[ Price : $8.95]

FDA issues iRhythm Technologies a Form FDA-483 after an inspection last month cited three GMP deficiencies.

HHS Assists FDA with BDs Bactec Shortage

[ Price : $8.95]

HHS says it is working with FDA to help resolve an ongoing supply shortage of BDs Bactec blood culture media bottles.

Imfinzi OKd for Resectable Lung Cancer

[ Price : $8.95]

AstraZeneca gains FDA approval for Imfinzi (durvalumab) with platinum-containing chemotherapy for adults with resectable non-small...

Court Nixes Restraining Order Request in Entresto Suit

[ Price : $8.95]

The Washington DC District Court rejects a Novartis motion in a generic drug carve-out case for a preliminary injunction to stay F...

Class 2 for Nucleic Acid Covid Tests

[ Price : $8.95]

Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify nucleic acid targets in resp...