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FDA OKs Major Yescarta, Tecartus REMS Changes

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FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.

4 Observations in Dr. Reddys Inspection

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FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingred...

Inspection Delay, Denial, Limit, Refusal Guidance

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FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device ins...

FDA Abandoning Biosimilar Switching Studies

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FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability...

20 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 20 ANDAs from multiple applicants after they notified the agency that the drug ...

Jazz Tremor Drug Misses Primary Endpoint

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Jazz Pharmaceuticals says data from its Phase 2b clinical trial evaluating the efficacy and safety of suvecaltamide in adult patie...

J&J Seeks Tremfya Crohns Indication

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Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.

De Novo for Onkos Implant Antibacterial Coating

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FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants.

FDA OKs New Skyrizi Indication

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FDA approves a new ulcerative colitis indication for AbbVies Skyrizi.

Target Health ANDA Withdrawals Notice Corrected

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Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target...