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Pfizers Talzenna Gets Updated Label

[ Price : $8.95]

FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastati...

Roche Advancing Parkinsons Drug Into Phase 3

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Roche moves prasinezumab into a Phase 3 trial after two mid‑stage trials and their open‑label extensions hinted at a d...

Milestone Pharma Files NDA Resubmission for Cardamyst

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

Zyno Medical Recalls Infusion Pumps

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

Qalitex Warns of Growing FDA-Amazon Enforcement Overlap

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

AbbVie's Venetoclax Fails to Improve Survival in Trial

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

Incyte Reports Positive Data on Neoplasm Drug

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

Sumitomo Pharma Gets Fast Track Status for Nuvisertib

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

Nipro Class 1 Recall of Hemodialysis Chemical

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

FDA Delays Hereditary Angioedema NDA Decision

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