FDA

FDA Articles

In an incredible move on Friday, the FDA approved Endari for the treatment of patients age five and older with sickle cell disease to reduce severe complications that are common with the blood...
Cara Therapeutics saw its shares rise on Friday after the company said that the FDA granted a Breakthrough Therapy designation on its uremic pruritus treatment.
Rigel Pharmaceuticals watched its shares make a handy uptick on Monday after the FDA approved its New Drug Application for the use of Tavalisse in patients with chronic or persistent immune...
Omeros saw its shares make a handy gain on Tuesday after the company announced that the FDA granted a Breakthrough Therapy designation for its treatment for IgA nephropathy.
Akebia Therapeutics saw its shares hit a new 52-week high in Tuesday’s session following a key licensing agreement with Vifor Pharma.
It is no secret that pharma and biotech shares have had to deal with at least some headwinds over the past year. It turns out that drug pricing concerns and political oversight can still be...
Immunomedics watched its shares make a massive gain on Friday after the company announced the termination of its licensing deal with Seattle Genetics.
Intra-Cellular Therapies saw its stock crumble early on Monday after the company provided an update on its plan to submit a New Drug Application for its treatment of schizophrenia.
When drugs are expected to get FDA approval and show positive data but don't, the underlying stocks of drug and biotech companies can see harsh punishment.
Esperion Therapeutics and a few other biopharma stocks made massive runs on Monday morning.
These are some of the biggest biopharma stocks moving on Wednesday, as markets have hit new intraday highs, continuing to climb in the wake of the White House announcements.
Evoke Pharma saw its shares jump on Wednesday after the company issued an update that it received from the FDA.
AMAG Pharmaceuticals shares took a sharp turn down after the company reported top-line results from its most recent pharmacokinetic study.
Trump said last week that companies in the health care sector are “getting away with murder,” and that something had to change. The sector has pulled back slightly since then, but there are still...
The the attacks against drug pricing and competition do not seem to be going away, but somehow, Merck has managed to find itself as a top pick for pharmaceutical and biohealth analysts.