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8 Repeat QS Violations at Edge Biologicals

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FDA warns Memphis, TN-based Edge Biologicals about eight repeated Quality System violations in its manufacturing of in vitro diagn...

Ambrx Gets Fast Track for Prostate Cancer Drug

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FDA grants Ambrx Biopharma a fast track designation for ARX517 for treating certain patients with metastatic castration-resistant ...

Nitric Oxide Delivery Device Recalled

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NOxBOX recalls its NOxBOXi Nitric Oxide Delivery System due to a check valve misalignment in the devices manifold.

FDA Clears ReddyPort Ventilation Device

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FDA clears the ReddyPort elbow device used in non-invasive ventilation.

4 Observations in SCA Pharmaceuticals FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Little Rock, AR-based SCA Pharmaceuticals outsourcing facility...

Keytruda Hits Endpoint in Cervical Cancer Trial

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Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of t...

FDA Clears Xstrahl Skin Cancer Radiation Therapy

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FDA clears an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer pat...

FDA Grants Fast Track for Myelofibrosis Drug

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FDA grants Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis.

FDA Boosts Translational Sciences Achievements

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The CDER Office of Translational Sciences 2022 annual report lists what it says were achievements in five areas of activity.

Legislators Hit FDA's India, China Inspections

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Bipartisan leaders of the House Energy and Commerce Committee express concerns about FDA foreign inspections and ask for answers t...