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FDA General

Rep. Pallone Blasts RFK Jr. Over Vaccine Changes

Rep. Frank Pallone Jr. (D-NJ) sharply criticizes Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of undermining vaccine access...

Medical Devices

FDA OKs Medtronics Altaviva Implant for Incontinence

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

Animal Drugs

10/9 Vaccines Panel to Recommend Flu Strain Selection

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

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Human Drugs

Mercks Keytruda Qlex Approved by FDA

FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric solid tumor indic...

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Medical Devices

Device Inspections Show Tougher Enforcement: Law Firm

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

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Medical Devices

FDA Reverts Lab Test Reg. After Court Ruling

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

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Human Drugs

FDA OKs Expanded Labeling for Asthma Drug

FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% reduction of severe exa...

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Human Drugs

Regeneron Plans Garetosmab FDA Submission

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

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Human Drugs

Leverage FDA Alternative Tools Flexibility: Attorneys

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

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Medical Devices

Alert on Abbotts TactiFlex Ablation Catheter

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