News Wire

The FDA has issued a warning letter to American CryoStem Corporation for marketing an adipose-derived stem cell product without the agency’s approval and for significant deviations from current good manufacturing practice requirements, including some that raise potentially significant safety concerns.…
Workers would be allowed to band together to buy health insurance under a proposed rule released by the Department of Labor, The Hill reported. The proposal was issued in response to an executive order by President Trump, which would allow associations of workers to purchase cheaper health insurance…
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union, according to a Reuters report. The E.U. recommended 92 new drugs, including generics, up from 81, and China laid out…
In just four months, high doses of vitamin D reduced arterial stiffness in young, overweight/obese, vitamin-deficient, but otherwise still healthy African-Americans, researchers say. Rigid artery walls are an independent predictor of cardiovascular-related disease and death, and vitamin D deficiency…
The FDA has approved valsartan oral solution (Prexxartan, Medicure), the first and only approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the United States. Previously, on October 31, 2017, Medicure announced that, through its subsidiary, Medicure International, Inc.,…
Teva Pharmaceutical Industries Ltd. has launched the first generic version of Reyataz (atazanavir, Bristol-Myers Squibb) capsules in the U.S. Atazanavir sulfate capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency…
The FDA has granted 510(k) clearance to Anika Therapeutics for a new hyaluronic-acid (HA)–based injection indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from…
The FDA has updated the product label for the cancer drug nilotinib (Tasigna, Novartis) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive…
A new noninvasive stereotactic radiotherapy system (GammaPod, Xcision Medical Systems, LLC) intended for use in treating cancer in breast tissue has received FDA approval. “… Patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast…
The FDA has approved Giapreza (angiotensin II injection, La Jolla Pharmaceutical Co.) for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. "Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death," said Norman…
The FDA has approved three new drugs for type-2 diabetes: Steglatro tablets (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor; Steglujan tablets (ertugliflozin/sitagliptin), the only fixed-dose combination of an SGLT2 inhibitor and the dipeptidyl peptidase-4 inhibitor sitagliptin;…
The FDA is removing boxed warnings about asthma-related deaths from the labels of drugs that combine long-acting beta agonists (LABAs) with inhaled corticosteroids (ICS) after studies showed such combinations don’t cause more serious asthma-related side effects than ICS treatment alone. However, using…
The FDA has approved pertuzumab (Perjeta, Genetech), in combination with trastuzumab (Herceptin, Genentech) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. People should receive the adjuvant pertuzumab-based regimen for one year. The FDA also…
Nivolumab (Opdivo, Bristol-Myers Squibb) has secured FDA approval for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Adjuvant therapy aims to reduce the risk of recurrence following surgical removal of the…
The FDA has approved a new indication for cabozantinib tablets (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer in adults. The FDA’s priority review and approval were based on results from the randomized phase 2 CABOSUN…

Pages