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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...

Guide on ANDA Pre-Submission Facility Correspondence

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FDA posts a final guidance entitled ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submis...

Senators Introduce Bill to Ban DTC Drug Advertising

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Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-consumer drug advertising.

Oncologic Panel to Review Multiple Myeloma BLA

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FDA schedules a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab maf...

Medtronic Newport Ventilator Recall Class 1

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FDA says a Medtronic recall of specified Newport ventilators is Class 1.

Questions Raised on New ACIP Members

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The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Imm...

Capricor Gets Form-483 After BLA Facility Inspection

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A recent FDA pre-license inspection of Capricor Therapeutics San Diego manufacturing facility for investigation cell therapy Deram...