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$FDA approves new osteoporosis drug for postmenopausal women with high fracture risk$

FDA approves new osteoporosis drug for postmenopausal women with high fracture risk

The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

9 Apr 2019

FDA approves two-drug complete regimen for previously untreated HIV-infected adults

The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

9 Apr 2019

FDA extends indication of metastatic breast cancer treatment to include male patients

The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

5 Apr 2019

FDA and CBP collaborate to protect public health and safety

The U.S. Food and Drug Administration and the U.S. Customs and Border Protection leaders signed an agreement today to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation's International Mail Facilities and Ports of Entry that pose a threat to public health.

4 Apr 2019

FDA issues warning letters to four homeopathic firms for CGMP violations

The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice regulations, including a letter to King Bio Inc. of Asheville, N.C.

2 Apr 2019

3D Bioprinting and its Applications

In this interview, AZoM speaks to members of SunP Biotech about 3D bioprinting and its applications.

From SunP Biotech 1 Apr 2019

Household dust may be contributing to childhood obesity epidemic

New research has found that chemicals found in household dust may promote fat cell development and contribute to increased weight gain in children.

1 Apr 2019

FDA approves new oral drug to treat relapsing forms of multiple sclerosis

The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease.

29 Mar 2019

FDA approves treatment for adults with non-radiographic axial spondyloarthritis

The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.

28 Mar 2019

FDA approves new oral treatment for men with certain forms of hypogonadism

The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.

27 Mar 2019

FDA approves new drug to treat adults with relapsing forms of MS

The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

27 Mar 2019

Chemicals in household dust promote development of fat cells in cell model

Endocrine-disrupting chemicals present in household dust promote the development of fat cells in a cell model and could contribute to increased growth in children relative to their age, according to research to be presented Monday, March 25 at ENDO 2019, the Endocrine Society's annual meeting in New Orleans, La.

25 Mar 2019

New device approved by FDA for treating patients with moderate-to-severe heart failure

The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat.

22 Mar 2019

Pharmaceutical and personal care products may result in new contaminants in waterways

When you flush the toilet, you probably don't think about the traces of the medicine and personal care products in your body that are winding up in sewage treatment plants, streams, rivers, lakes, bays and the ocean.

22 Mar 2019

FDA warns two breast implant makers for failure to comply with post-approval study requirements

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

20 Mar 2019

FDA approves first drug for treatment of postpartum depression in adult women

The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment of postpartum depression in adult women. This is the first drug approved by the FDA specifically for PPD.

20 Mar 2019

FDA warns marketer of unapproved products claiming to treat addiction, chronic pain

The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.

19 Mar 2019

FDA grants marketing authorization for new device to help treat carbon monoxide poisoning

The U.S. Food and Drug Administration today allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning.

14 Mar 2019

FDA takes action to help reduce risks linked with use of surgical staplers and staples

Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples - common devices used in many surgeries - and to provide updated recommendations to help reduce risks associated with their use.

11 Mar 2019

Novel 3D hydrogel helps researchers to quickly screen potential cancer drugs

A 3D hydrogel created by researchers in U of T Engineering Professor Molly Shoichet's lab is helping University of Ottawa researchers to quickly screen hundreds of potential drugs for their ability to fight highly invasive cancers.

26 Feb 2019