FDA

FDA Approves Firazyr to Treat Hereditary Angioedema Patients in US

FDA Approves Firazyr to Treat Hereditary Angioedema Patients in US

Food and Drug Administration of US has approved Firazyr to treat hereditary Angioedema patients. HAP is a swelling in subcutaneous tissues.

The treatment was approved in Europe in 2008, and now has got the approval of FDA for the patients aged above 18 years.

FDA approves Glaxo’s triple vaccine ‘Boostrix’ for 65-plus patients

FDA approves Glaxo’s triple vaccine ‘Boostrix’ for 65-plus patients

On Friday, US Food and Drug Administration (FDA) gave its approval to GlaxoSmithKline's triple vaccine ‘Boostrix’ – which is a combination vaccine for tetanus, diphtheria and pertussis (whooping cough) - for patients aged more than 65 years.

FDA Criticizes Australian Biotech over Inadequate Investigation

FDA Criticizes Australian Biotech over Inadequate Investigation

The powerful United States Food and Drug Administration has released a warning letter to Australian Biotech giant CSL regarding the companies handling of an internal investigation into flu vaccine problems that affected more than 410 children last spring.

FDA approves NovoTFF – first-of-a-kind device for brain cancer

FDA approves NovoTFF – first-of-a-kind device for brain cancer

According to the information shared by the Israel-based device maker Novocure on Friday, the US Food and Drug Administration (FDA) has recently given its approval to a new, wearable device - the portable NovoTFF 100-A System - which fights glioblastoma brain tumors using an electrical field.

FDA Recommendation for ADHD drugs Remains Unchanged

FDA Recommendation for ADHD drugs Remains Unchanged

The Food and Drug Administration (FDA) has delayed its decision regarding changes to be made in the safety instruction of popular medicines as Vyvanse and Adderall. FDA said that it will be giving a full update after the final analyses on the potential impact of stimulants ADHD drugs on the risk of heart disease and strokes were evaluated. The drugs are used to treat hyperactivity.

Not enough evidence to link hyperactivity to artificial coloring

Not enough evidence to link hyperactivity to artificial coloring

There were calls on the necessity of a warning label stating restrictions on foods that are processed but not adequate evidence was suggested by expert advisory panel that discussed on the issue to the Food and Drug Administration when it comes to hyperactivity being linked to artificial colors.

Ulcer Drug Might Lead to Bone Fracture If Taken for Longer Period

Ulcer Drug Might Lead to Bone Fracture If Taken for Longer Period

The Food and Drug Administration (FDA) has declared that the chances of severe fracture is very less, in case of those ulcer patients, who take low dose of Proton-Pump Inhibitors (PPI) and for a shorter duration.

Merck’s Shares Topple down over FDA Rejection

Merck’s Shares Topple down over FDA Rejection

German Merck is most likely to lose the battle against the Switzerland’s Novartis AG. As per the reports, the Food and Drug Administration (FDA) has asked Merck to produce concrete evidence to study the potential effects of the multiple sclerosis (MS) pill cladribine on the health of patients.

Medical Devices Got Little FDA Scrutiny

Medical Devices Got Little FDA Scrutiny

According to the reports, 113 medical devices were recalled by the FDA between 2005 and 2009 because they were dangerous. Out of them 81 percent had been cleared under a lenient process reserved for devices deemed "substantially equivalent" to others already approved. This has revealed a critical flaw in the federal review system.

FDA Traces A New Device Approval Path

FDA Traces A New Device Approval Path

According to the reports, the Food and Drug Administration of US has proposed a new way for breakthrough medical devices to be approved by the agency.

On Tuesday, in a briefing agency officials said that a new Innovation Pathway is part of an initiative designed to help cutting-edge products win quicker clearance than earlier.

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