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About 10 percent of cases where a drug does serious harm are not reported to the U.S. Food and Drug Administration within the required 15-day period

Delays Noted in the Reporting of Serious Patient Harms to FDA

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Analysis found roughly 10 percent of cases were filed after 15-day deadline passed
A new diagnostic to differentiate between HIV-1 antibodies

FDA Approves Test to Differentiate HIV Viruses

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Among people two years and older
Technivie (ombitasvir

FDA Approves Technivie for Hepatitis C

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For people with chronic hepatitis C genotype 4
Odomzo (sonidegib) has been approved by the U.S. Food and Drug Administration to treat locally advanced basal cell carcinoma that has returned despite surgery or radiation. The treatment is sanctioned for people who are not candidates for additional surgery or radiation.

FDA Approves Odomzo for Recurring Basal Cell Carcinoma

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Medication is designed to inhibit the Hedgehog pathway
A prosthesis for people with above-the-knee amputations who cannot use a conventional device has been approved by the U.S. Food and Drug Administration.

FDA Approves Novel Leg Prosthesis for AKAs

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New device adheres to the leg with fixtures and screws implanted into the remaining thigh bone
Rexulti (brexpiprazole) has been approved by the U.S. Food and Drug Administration to treat schizophrenia

FDA Approves Rexulti for Schizophrenia, Depression

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But shouldn't be prescribed to some older people
Iressa (gefitinib) has been approved by the U.S. Food and Drug Administration to treat patients with metastatic non-small-cell lung cancer with a specific genetic mutation (epidermal growth factor receptor [EGFR]). A just-approved companion diagnostic test can identify patients who could benefit from this new use.

FDA Approves Iressa for EGFR+ Metastatic Lung Cancer

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New companion diagnostic kit can identify candidates
The U.S. Food and Drug Administration on Tuesday approved the drug Entresto (sacubitril/valsartan) to treat heart failure.

FDA Approves Entresto for Heart Failure

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Medication helps reduce the rate of cardiovascular death, hospitalization
Kengreal (cangrelor) has been approved by the U.S. Food and Drug Administration to prevent blood clots from forming during angioplasty.

FDA Approves New Antiplatelet Drug for Patients Undergoing PCI

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Kengreal prevents blood platelets from accumulating during percutaneous coronary intervention
The U.S. Food and Drug Administration

FDA Cracks Down on Online Sale of Illegal Medical Products

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International effort takes aim at more than 1,050 websites