The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...

The agency issued a request for more information that will shape new regulation on ingredient transparency.

FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label ...

FDA requests information to explore whether current gluten labeling rules adequately protect consumers, with implications for ...

The FDA has requested new human factors and pharmacology studies for Anaphylm sublingual film following deficiencies in original NDA packaging data.

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, ...

The U.S. Food and Drug Administration (FDA) is taking active steps to improve disclosure of gluten ingredients in foods.

The FDA proposes front-of-package "Nutrition Info boxes" to highlight saturated fat, sodium, and added sugars. The initiative aims to combat chronic diseases and promote healthier food choices. Large ...

The FDA approved re-administration of iDose TR for patients with healthy corneas, enhancing treatment flexibility for ...

Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Anaphylm (dibutepinephrine) Sublingual Film, a noninvasive ...

Hospital beds are a brutally concrete resource. When they're full, surgeries get delayed, hallways become overflow wards, and staff burn out. So a question I keep coming back to is simple: can the way ...

Delve into the Amarin v. Hikma case in which the U.S. Supreme Court might settle the skinny label question once and for all.