Diseases, Conditions, Syndromes

Test maker targeted by FDA says it responded to US concerns

A company targeted by the Food and Drug Administration for selling unauthorized coronavirus antibody tests says it has responded to regulators' concerns, though it has no business operations in the U.S.

Attention deficit disorders

US approves first 'digital therapeutic' game for ADHD (Update)

US health officials have approved the first game-based treatment for children with attention deficit hyperactivity disorder, part of a trend toward "digital therapeutics" or software to address certain conditions.

Medications

US revokes emergency use of malaria drugs vs. coronavirus

U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don't work and could cause serious side effects.

Obstetrics & gynaecology

New contraceptive gel, from bench to FDA approval

Research into the development of a new vaginal gel, initiated by UniSA Pharmaceutical Scientist, Professor Sanjay Garg, has now been approved by the US FDA as the first and only non-hormonal contraceptive.

Oncology & Cancer

Colorado tool, My-DST, may pick best multiple myeloma treatment

In 1844, multiple myeloma was first treated with a rhubarb pill and an infusion of orange peel. Since then, more than 15 drugs have earned FDA approval to treat multiple myeloma and with so many options, a major question ...

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Food and Drug Administration (United States)

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

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