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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...

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...

Optical Melanoma Detection Device Reclassified

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Federal Register notice: FDA proposes to reclassify optical diagnostic devices for melanoma detection and electrical impedance spe...