Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...

FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for ...

Cheap, illegal imported vaping products from China have harmed young people in Tennessee. Stop illegal access, but keep regulated products available.

The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more ...

"I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to ...

Analysts expect Sun to continue to be more aggressive in chasing speciality assets, but a successful launch is necessary for the stock to gain brownie points.

Cultivated meat company Mission Barns has received a “No Questions” letter from the U.S. Food and Drug Administration (FDA), ...

Chemicals such as titanium dioxide and potassium bromate, whose safety has been debated, are allowed in foods in the United ...

One Source Nutrition, Inc. is voluntarily recalling all of its Vitality male enhancement capsules nationwide after an FDA ...