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Lexicon Refiles NDA for Sotagliflozin

[ Price : $8.95]

After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an ad...

Dj vu: Marks Overrides Reviewers on Duchenne Drug Again

[ Price : $8.95]

CBER director Peter Marks again overrides his Centers review teams in approving a supplemental BLA that expands the approval and c...

Zoll Recalls Ventilators Over Operator Guides

[ Price : $8.95]

Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.

Clinical Hold Lifted on Huntingtons Drug

[ Price : $8.95]

FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase...

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FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability...

20 No-Longer-Marketed ANDAs Withdrawn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...