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Human Drugs

Milestone Pharma Files NDA Resubmission for Cardamyst

Milestone Pharmaceuticals submits its response to a March-issued FDA complete response letter on the companys NDA for irregular heart beat drug Cardam...

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Medical Devices

Zyno Medical Recalls Infusion Pumps

Zyno Medical recalls certain Z-800 infusion pumps because they were released to customers with incorrect software versions.

Human Drugs

Qalitex Warns of Growing FDA-Amazon Enforcement Overlap

Qalitex Laboratories issues an alert to dietary supplement and wellness product sellers on Amazon about a growing overlap between FDAs enforcement and...

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Human Drugs

AbbVie's Venetoclax Fails to Improve Survival in Trial

An AbbVie Phase 3 (VERONA) clinical trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndro...

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Human Drugs

Incyte Reports Positive Data on Neoplasm Drug

Incyte reports the first positive clinical data from studies evaluating a novel, first-in-class targeted monoclonal antibody in patients with mutant c...

Animal Drugs

Sumitomo Pharma Gets Fast Track Status for Nuvisertib

FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.

Medical Devices

Nipro Class 1 Recall of Hemodialysis Chemical

Nipro recalls its MedicaLyte liquid bicarbonate concentrate after confirming bacterial and fungal contamination in returned products.

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Human Drugs

FDA Delays Hereditary Angioedema NDA Decision

FDA delays a review decision on a KalVista Pharmaceuticals NDA for sebetralstat, indicated for treating hereditary angioedema.

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Human Drugs

Keytruda OKd for Head-Neck Cancer Pre/Post-Surgery

FDA approves Mercks Keytruda (pembrolizumab) as the first anti‑PD‑1 therapy that can be given both before and after surgery for adults wit...

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Human Drugs

FDA Clinical Hold on Pulmonary Fibrosis Drug

FDA places a clinical hold on a Rein Therapeutics Phase 2 (RENEW) trial of LTI-03 due to agency requests for additional non-clinical information.