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Pfizer NDA Approved for Prostate Cancer

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FDA approves a Pfizer NDA for Talzenna (talazoparib) with Astellas Xtandi (enzalutamide) for treating certain patients with gene-m...

Harvard Drug Recalls Drugs Due to Mislabeling

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The Harvard Drug Group recalls a single lot of dronabinol capsules (2.5 mg) and ziprasidone hydrochloride capsules (20 mg) after r...

Review Extended on GSKs Momelotinib

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FDA extends by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia.

Philips Safety Alert on Azurion/Allura Devices

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Philips issues an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which c...

FDA Posts 483 of iRhythms CA Facility

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A just-posted, four-item Form FDA-483 sheds light on medical device reporting and other violations cited in a 2022 inspection of i...

Emigality Misses Superiority in Clinical Trial

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Eli Lilly says a head-to-head clinical trial comparing its migraine drug Emgality (galcanezumab-gnlm) to Pfizers Nurtec ODT (Rimeg...

FDA OKs Premia Spine Fusion Alternative

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FDA approves Premia Spines TOPS System as an alternative to spinal fusion for treating certain patients with degenerative spondylo...

CVM Guide on Soluble Powder Bioequivalence

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FDA publishes a CVM guidance entitled #171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Me...

Columvi Accelerated Approval for Lymphoma

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FDA grants Genentech accelerated approval for its BLA for Columvi (glofitamab-gxbm) and its use in treating adult patients with re...

Positive Data Added to BMS Heart Drug Label

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FDA approves a Bristol Myers Squibb supplemental NDA to add positive data from its Phase 3 VALOR-HCM study to the U.S. prescribing...