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Tandem Recalls t:slim Insulin Pumps

[ Price : $8.95]

Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-rel...

FDA OKs Corstasis Therapeutics Edema Nasal Spray

[ Price : $8.95]

FDA approves a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to cong...

FDA Cites Olympia Pharma Over GMPs

[ Price : $8.95]

FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firms Orlando, FL manufacturin...

CBER to Host Gene Therapy Manufacturing Town Hall

[ Price : $8.95]

CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.

FDA Pushes Plan to Scale Back Advisory Committees

[ Price : $8.95]

FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice...

Alternative Facility Assessment Tools Guidance

[ Price : $8.95]

FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.

CBER Says AstraZeneca FluMist Ad Misled Viewers

[ Price : $8.95]

CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement ...

Respironics Recalls DreamStation Ventilators

[ Price : $8.95]

Philips Respironics recalls (Class 1) certain DreamStation auto continuous positive airway pressure and auto bilevel positive airw...

Makary JAMA Piece Explains DTC Ad Crackdown

[ Price : $8.95]

FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to rein in direct-to-consumer pha...

Intercept Withdraws Ocaliva Amid Liver Safety Concerns

[ Price : $8.95]

Intercept Pharmaceuticals withdraws Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis, foll...