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Comments on Medical Device VIP Program Draft Guidance

[ Price : $8.95]

Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.

Intercept to Resubmit Obeticholic Acid NDA

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Intercept Pharmaceuticals says it will resubmit an NDA to FDA for its obeticholic acid to treat patients with liver fibrosis due t...

FDA Seeks Consumer Reps for Advisory Committees

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...

FDA Copiktra Warning About Higher Risk of Death

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FDA says clinical trial results show an increased risk of death and serious side effects associated with Secura Bios cancer drug C...

LiveMetric 510(k) for Wrist Nano Sensor BP Monitor

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FDA clears a LiveMetric 510(k) for its LiveOne, a wrist-worn nano-sensor technology for monitoring blood pressure every 10 seconds...

Regulatory Review Period for Imcivree

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rhythm Pharmaceuticals Imci...

AFT Pharma Complete Response on Pain Killer Combo

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FDA issues AFT Pharmaceuticals a complete response letter on its NDA for Maxigesic IV, a combination of 1,000 mg paracetamol and 3...

Philips and Biodesix Team Up on Lung Cancer Management

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Royal Philips teams up with Biodesix to add the results of Biodesixs Nodify Lung blood-based lung nodule risk assessment testing i...

Genmab Filing BLA for Large B-cell Lymphoma Therapy

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Genmab says it will submit in the second half of this year a BLA for subcutaneous epcoritamab, an investigational bispecific antib...

FDA OKs PreventionGenetics Companion Diagnostic

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FDA approves PreventionGenetics POMC/PCSK1/LEPR companion diagnostic genetic test for use with Rhythm Pharmaceuticals Imcivree (se...