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FDA OKs Medtronics Altaviva Implant for Incontinence

[ Price : $8.95]

FDA approves Medtronics Altaviva implantable tibial neuromodulation device for treating urge urinary incontinence.

10/9 Vaccines Panel to Recommend Flu Strain Selection

[ Price : $8.95]

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain sel...

Mercks Keytruda Qlex Approved by FDA

[ Price : $8.95]

FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatr...

Device Inspections Show Tougher Enforcement: Law Firm

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FDA escalates medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in o...

FDA Reverts Lab Test Reg. After Court Ruling

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FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.

Regeneron Plans Garetosmab FDA Submission

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Regeneron says it will submit an application to FDA by the end of 2025 seeking approval for its garetosmab to treat adults with fi...

Leverage FDA Alternative Tools Flexibility: Attorneys

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Three Sidley attorneys suggest ways drug companies can take advantage of the flexibility in FDAs guidance on using alternative too...

Alert on Abbotts TactiFlex Ablation Catheter

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FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing ...

6 Observations in Fagron Outsourcing Inspection

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FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.

FDA Approves 2 Biocon Denosumab Biosimilars

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FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.