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Lexicon Wins Approval for Heart Failure Drug

[ Price : $8.95]

FDA approves a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascul...

Chirocaine Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Purdue Pharmas Chirocaine (levobupivacaine) injection was not withdrawn due to safety...

Sitravatinib Fails in Phase 3 Lung Cancer Study

[ Price : $8.95]

Mirati Therapeutics says its sitravatinib failed to meet the primary endpoint in the Phase 3 SAPPHIRE lung cancer study.

Power Morcellation Tissue Containment Guidance

[ Price : $8.95]

FDA publishes a guidance with recommendations to help manufacturers comply with the special controls related to non-clinical perfo...

Trial Covariate Adjustment Guidance

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FDA publishes a guidance with its recommendations on adjusting for covariates in the statistical analysis of randomized clinical t...

Drug, Medical Device Recalls Up in 1st Quarter

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The latest Sedgwick recall index report details increases in drug and medical device recalls in the first quarter of 2023 over the...

FDA Orphan Drug Status for Felzartamab

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FDA grants Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary ...

Act on Cancer Chemo Shortages: Michigan Reps

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Michigan members of the House of Representatives urge quick FDA action to address shortages of three chemotherapy drugs.

Pfizer Paxlovid NDA Approved for Covid

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FDA approves a Pfizer NDA for its antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets) for treating mild-to-moderate Co...

Generally Accepted Scientific Info in NDAs/BLAs

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Federal Register notice: FDA releases a draft guidance entitled Generally Accepted Scientific Knowledge in Applications for Drug a...