The Food and Drug Administration (FDA) recently gave Apple the green light to use software that may help million of people ...
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
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 ...
Q3 2024 Earnings Call Transcript November 9, 2024 Operator: Greetings, and welcome to the Achieve Life Sciences Third Quarter ...
Mind Medicine’s share price has responded very strongly to Q3 update that contained very little new information. Read why I ...
Phenylephrine is both the most common decongestant on pharmacy shelves, and arguably the worst at its job. Last year, the FDA ...
RYTELOâ„¢ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent ...
The FDA late Thursday approved berotralstat, a drug the Durham company developed to prevent HAE attacks in adults and children 12 and older. The company will market the capsule under the name Orladeyo ...
The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened ...
Journey Medical said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term ...