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FDA approves first treatment to reduce risk of NSCLC progression

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

18 Feb 2018

FDA permits marketing of first blood test to evaluate mild traumatic brain injury

The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults.

15 Feb 2018

FDA approves new treatment for non-metastatic, castration-resistant prostate cancer

The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.

15 Feb 2018

FDA approves new radioactive drug for treatment of rare digestive tract cancers

The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

29 Jan 2018

FDA grants approval for first drug to treat inherited breast cancer

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation.

15 Jan 2018

FDA gives marketing approval for first shock wave device to treat diabetic foot ulcers

Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

2 Jan 2018

FDA approves drug to increase blood pressure in adults with septic or distributive shock

The U.S. Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.

21 Dec 2017

FDA approves new gene therapy targeting rare form of inherited vision loss

The U.S. Food and Drug Administration today approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness.

19 Dec 2017

FDA announces new approach for sharing updates on antibiotics, antifungal drugs to physicians

Today the U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance.

14 Dec 2017

First short-acting ‘follow-on’ insulin receives FDA approval to treat diabetes

The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

12 Dec 2017

FDA grants approval to first biosimilar for treatment of patients with breast, stomach cancers

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).

4 Dec 2017

Scientists identify two Corynebacteria species as potential targets to improve skin appearance

Today, Amway Corporation, in collaboration with Microbiome Insights, Inc. presented results from two independent epidemiology studies at Happi's Anti-Aging Conference & Tabletop Exhibition, an annual conference that attracts anti-aging industry experts and suppliers.

30 Nov 2017

Chemical imaging can provide comprehensive information about the skin

A new method of examining the skin can reduce the number of animal experiments while providing new opportunities to develop pharmaceuticals and cosmetics.

29 Nov 2017

FDA approves first medical device system that can make adjustments to implanted lens after cataract surgery

The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not using glasses.

22 Nov 2017

FDA approves remote programming feature for Nucleus Cochlear Implant System via telemedicine

The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

20 Nov 2017

FDA approves first adjuvant treatment to reduce risk of kidney cancer recurrence

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy).

17 Nov 2017

FDA approves new drug to treat bleeding in hemophilia A patients

The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.

17 Nov 2017

FDA permits marketing of first electric stimulation device to reduce opioid withdrawal symptoms

Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.

16 Nov 2017

FDA approves drug to treat pediatric, adult patients with rare Sly syndrome

The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and organs.

15 Nov 2017

FDA warns consumers about injuries, disfigurement from using illegal injectable silicone

The U.S. Food and Drug Administration today issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts.

14 Nov 2017