fda

Would Device-Specific ICD-9 Codes Shed Light on Safety?

Would Device-Specific ICD-9 Codes Shed Light on Safety?

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The current post-approval process also does not provide the FDA with a picture of how often a device is used, but having device-specific ICD codes would change that.

FDA Approves Mavyret for Treatment of Hepatitis C

FDA Approves Mavyret for Treatment of Hepatitis C

Mavyret has been approved by the FDA to treat adults with certain types of chronic hepatitis C virus.

FDA Reviewing Potential First US Gene Therapy

FDA Reviewing Potential First US Gene Therapy

Tisagenlecleucel could be a one-time treatment for children and young adults with advanced leukemia.

Endari Approved by FDA to Treat Sickle Cell Disease

Endari Approved by FDA to Treat Sickle Cell Disease

The FDA has approved the first treatment for patients with sickle cell disease in almost 20 years.

FDA Aims to Increase Number of Generic Drugs on the Market

FDA Aims to Increase Number of Generic Drugs on the Market

The agency will now give priority reviews to new generic drugs until there are at least 3 available.

First Generic Version of Truvada Approved by FDA

First Generic Version of Truvada Approved by FDA

The generic version has been approved for treatment of HIV-1, in combination with other antiretroviral agents or for PrEP.

Radicava Approved to Treat Amyotrophic Lateral Sclerosis

Radicava Approved to Treat Amyotrophic Lateral Sclerosis

Radicava, given intravenously, slows physical decline in patients with ALS.

Companies Selling Fraudulent Cancer Treatments, FDA Warns

Companies Selling Fraudulent Cancer Treatments, FDA Warns

The unapproved products are often advertised as 'natural' and labeled as supplements.

First Drug to Treat Tardive Dyskinesia Approved by FDA

First Drug to Treat Tardive Dyskinesia Approved by FDA

Ingrezza capsules were approved for treatment of adults with tardive dyskinesia.

Lack of Negative Clinical Trial Data Concerning for Major Health Organizations

Lack of Negative Clinical Trial Data Concerning for Major Health Organizations

Health organizations, such as the WHO, FDA, and NIH have raised ethical challenges about the way clinical trial data is reported.

FDA Approves Various Direct-to-Consumer Genetic Risk Tests

FDA Approves Various Direct-to-Consumer Genetic Risk Tests

Saliva analysis can indicate a higher risk of Parkinson's disease, among others, the agency says.

New Drug Approved by FDA to Treat Various Female Cancers

New Drug Approved by FDA to Treat Various Female Cancers

The PARP inhibitor may help fight tumors affecting the ovaries, fallopian tubes or peritoneum.

FDA Approves 'Bavencio' for Merkel Cell Carcinoma Treatment

FDA Approves 'Bavencio' for Merkel Cell Carcinoma Treatment

This drug targets the PD-1/PD-L1 pathway and is the first sanctioned treatment in the United States.

FDA Approves Latest Add-on Drug 'Xadago' for Parkinson's Disease

FDA Approves Latest Add-on Drug 'Xadago' for Parkinson's Disease

This medication aims to help prevent 'off' episodes among users of levodopa/carbidopa.

FDA Approves Noctiva to Treat Nocturnal Polyuria

FDA Approves Noctiva to Treat Nocturnal Polyuria

This drug is designed to increase the absorption of water through the kidneys and decreasing urine production.

FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

Oral tablets are to be used in combination with somatostatin analog therapy.

Emflaza Approved by FDA to Treat Duchenne Muscular Dystrophy

Emflaza Approved by FDA to Treat Duchenne Muscular Dystrophy

This drug was approved to treat Duchenne muscular dystrophy in patients 5 years and older.

Additional Newborn Screening Tests for Metabolic Disorders Approved by FDA

Additional Newborn Screening Tests for Metabolic Disorders Approved by FDA

These detect Mucopolysaccharidosis Type 1, Pompe, Gaucher and Fabry.

Trulance Now FDA Approved for Chronic Idiopathic Constipation

Trulance Now FDA Approved for Chronic Idiopathic Constipation

This drug is designed to stimulate secretions of intestinal fluid.

FDA, EPA Issues New Guidance on Fish Consumption

FDA, EPA Issues New Guidance on Fish Consumption

Recommendations are aimed at pregnant women, breastfeeding mothers and parents of young children.

Higher Drug Prices Driven by Excessive FDA Regulations

Higher Drug Prices Driven by Excessive FDA Regulations

First-in-class drugs are fast-tracked, while follow-on drugs can take up to 15 years to be approved.

Ovarian Cancer Drug Granted Accelerated Approval by FDA

Ovarian Cancer Drug Granted Accelerated Approval by FDA

Rubraca's use is specific to women with deleterious BRCA mutations.

FDA Releases Safety Info About Anesthesia Use

FDA Releases Safety Info About Anesthesia Use

This new information addresses anesthesia use in pregnant women and young children.

FDA Discusses Dependence and Misuse of Testosterone Products

FDA Discusses Dependence and Misuse of Testosterone Products

The agency warns that many American men take testosterone products, but heart and psychological issues can result.

New Drug to Treat Advanced Soft Tissue Sarcomas Approved by the FDA

New Drug to Treat Advanced Soft Tissue Sarcomas Approved by the FDA

Lartruvo has been sanctioned for use with doxorubicin in cases that cannot be treated with radiation or surgery alone.

First Ever Drug for Duchenne Muscular Dystrophy Approved by FDA

First Ever Drug for Duchenne Muscular Dystrophy Approved by FDA

The FDA has just approved the drug, Exondys 51, to treat patients with a mutation of the dystrophin gene amenable to exon 51 skipping in DMD.

Special Edition

Special Edition

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The FDA and the pharmaceutical industry work hand-in-hand to deliver "lifesaving" drugs to Americans. But whose lives are really being saved?

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