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FDA approves marketing of brainsway deep transcranial magnetic stimulation system for OCD

Today, the U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD).

17 Aug 2018

FDA grants approval for first generic version of epinephrine auto-injector

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.

16 Aug 2018

Finding the light in antimicrobials

Hundreds of polymers which kill drug-resistant superbugs in novel ways could be produced and tested using light, using this new method.

14 Aug 2018

FDA permits marketing of first mobile medical app for contraceptive use to prevent pregnancy

The U.S. Food and Drug Administration today permitted marketing of the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy.

13 Aug 2018

FDA approves first oral medication for treatment of adults with Fabry disease

The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

10 Aug 2018

FDA approves first vaginal ring contraceptive that can be used for one year

The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

10 Aug 2018

FDA approves first targeted RNA-based treatment for rare, fatal genetic disease

The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.

10 Aug 2018

FDA flags risks linked to improper use of ROM tests

The U.S. Food and Drug Administration today alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman's water has broken (also known as a rupture of the membranes containing amniotic fluid).

9 Aug 2018

FDA approves potassium chloride oral solution as first generic drug to receive CGT designation

The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy designation.

9 Aug 2018

FDA approves drug for rare, hard-to-treat types of non-Hodgkin lymphoma

The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

8 Aug 2018

UCLA study demonstrates use of magnetic force to manage chronic pain

UCLA bioengineers have demonstrated that a gel-like material containing tiny magnetic particles could be used to manage chronic pain from disease or injury. Broadly, the study demonstrates the promising use of biomechanical forces that push and pull on cells to treat disease.

7 Aug 2018

FDA issues scientific recommendations to encourage development of novel drugs for treatment of OUD

The U.S. Food and Drug Administration today issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs for the treatment of opioid use disorder.

7 Aug 2018

FDA approves first therapy for patients with rare tumors of the adrenal gland

The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy.

31 Jul 2018

New project explores health effects of dangerous chemicals

The EDC-MIXRISK project is exploring the health effects of a group of man-made substances that have been shown to disrupt the body’s endocrine system, the collection of hormone-producing glands that regulate growth and development, metabolism, reproduction and even mood and sleep patterns.

23 Jul 2018

Key questions to consider for sustainable management of environmental risks in Europe

What are the most aggressive chemical products for the environment? What areas of the planet have more pollutants? Can we detect toxic products which are hard to identify? How can we protect biodiversity and natural ecosystems better?

23 Jul 2018

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.

20 Jul 2018

FDA grants approval for first breast cancer drug through 'Real-Time Oncology Review'

The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

19 Jul 2018

FDA warns consumers about criminals sending fake warning letters

The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

16 Jul 2018

FDA expands its support for states to implement FSMA Produce Safety Rule

The U.S. Food and Drug Administration today announced new cooperative agreements with Hawaii, Kentucky and Mississippi, as well as renewed agreements with 43 other states, in support of efforts to implement the FDA Food Safety Modernization Act Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

13 Jul 2018

Federal judge enters consent decree against Minnesota dairy farm for selling adulterated meat

U.S. District Judge Wilhelmina M. Wright for the District of Minnesota entered a consent decree of permanent injunction against Todd & Patty Meech Dairy Farm of Sebeka, Minn., and the farm's owners, Todd Meech and Patty Meech, for introducing adulterated meat into interstate commerce and for failing to comply with federal requirements for administering drugs to food-producing animals.

11 Jul 2018

Cosmetics News and Research

FDA approves marketing of brainsway deep transcranial magnetic stimulation system for OCD

FDA grants approval for first generic version of epinephrine auto-injector

Finding the light in antimicrobials

FDA permits marketing of first mobile medical app for contraceptive use to prevent pregnancy

FDA approves first oral medication for treatment of adults with Fabry disease

FDA approves first vaginal ring contraceptive that can be used for one year

FDA approves first targeted RNA-based treatment for rare, fatal genetic disease

FDA flags risks linked to improper use of ROM tests

FDA approves potassium chloride oral solution as first generic drug to receive CGT designation

FDA approves drug for rare, hard-to-treat types of non-Hodgkin lymphoma

UCLA study demonstrates use of magnetic force to manage chronic pain

FDA issues scientific recommendations to encourage development of novel drugs for treatment of OUD

FDA approves first therapy for patients with rare tumors of the adrenal gland

New project explores health effects of dangerous chemicals

Key questions to consider for sustainable management of environmental risks in Europe

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

FDA grants approval for first breast cancer drug through 'Real-Time Oncology Review'

FDA warns consumers about criminals sending fake warning letters

FDA expands its support for states to implement FSMA Produce Safety Rule

Federal judge enters consent decree against Minnesota dairy farm for selling adulterated meat

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