USFDA

FDA approves Novartis Piqray® - for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer

  • Posted on: 27 May 2019
  • By: PharmaTutor News

Novartis announced the US Food and Drug Administration (FDA) has approved Piqray (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

  • Posted on: 21 May 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems.

FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards

  • Posted on: 15 May 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Four of the warning letters pertain to companies who jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their purportedly sterile products were not shown to be sterile. An additional letter outlines a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.

FDA policy advancements to help bring interchangeable biosimilars to market

  • Posted on: 14 May 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

  • Posted on: 11 May 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

  • Posted on: 11 May 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for use in adults.

First FDA-approved vaccine for the prevention of dengue disease in endemic regions

  • Posted on: 4 May 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

FDA approves device to help increase access to more lungs for transplant

  • Posted on: 1 May 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant.

FDA approves first targeted therapy for metastatic bladder cancer

  • Posted on: 17 April 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.

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