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Sumitomo Pharma Gets Fast Track Status for Nuvisertib

[ Price : $8.95]

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

Roche Advancing Parkinsons Drug Into Phase 3

[ Price : $8.95]

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

[ Price : $8.95]

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...

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.

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

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

FDA Clinical Hold on Pulmonary Fibrosis Drug

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