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

Sen. Rick Scott (R-Fla.) on Thursday unveiled legislation that would require prescription drug labels to include information ...

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

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 ...

The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including ...

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

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

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