The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...

Phenylephrine is both the most common decongestant on pharmacy shelves, and arguably the worst at its job. Last year, the FDA ...

Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...

An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.

Though the company provided some records, FDA noted that these documents lacked clarity and approval by qualified FSVP personnel. Paso Real Produce LLC, based in Pharr, TX, received an FDA warning ...

Mind Medicine’s share price has responded very strongly to Q3 update that contained very little new information. Read why I ...

Lexicon Pharmaceuticals shares have been halted all day as a Food and Drug Administration advisory committee was scheduled to vote on Zynquista as an adjunct to insulin therapy for glycemic control in ...

Fadanelli is accused of lying to clients and employees about being a registered nurse and performing thousands of injections ...

Building upon a successful end-of-Phase 2 meeting, received FDA “Study May Proceed” letter for pivotal ... into first-line HCC pivotal Phase 3 trial Received final funding approval from NCI to move ...

While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external ...

While dapagliflozin (Farxiga) and empagliflozin (Jardiance) are approved for CKD in ... In briefing documents ahead of the meeting, FDA staff noted that seven incident cases of DKA occurred ...