FDA

FDA Articles

Akorn shares dipped on Tuesday after the firm announced that it received a warning letter from the FDA related to the inspection of its Somerset, New Jersey, manufacturing facility in July and August...
Ocular Therapeutix shares jumped on Friday after the firm announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Dextenza to include the...
Melinta Therapeutics shares nearly doubled early on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for...
Contents of some herbal supplements sold across the country in vitamin and nutrition stores may pose a significant danger to some people. The FDA is warning that pregnant women are particularly at...
Nabriva Therapeutics shares dropped sharply on Wednesday after the firm received a warning from the FDA for the New Drug Application seeking marketing approval of Contepo (fosfomycin).
CRISPR Therapeutics shares jumped on Tuesday after the firm announced that the FDA has granted Fast Track Designation for its treatment for transfusion-dependent beta thalassemia.
Zogenix shares were crushed on Tuesday after the firm provided an update from the FDA regarding Fintepla for the treatment of seizures associated with Dravet syndrome.
PhaseBio shares made a sizeble gain on Tuesday morning after the FDA provided a critical update for the firm.
Axsome shares jumped on Wednesday after the firm gave an update from the FDA regarding its AXS-05 for the treatment of major depressive disorder.
AbbVie and patients suffering from multiple myeloma have seen some additional bad news from the FDA.
In an incredible move for adolescent patients 12 to 17 years of age, the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for with moderate-to-severe atopic dermatitis.
It is supposed to be undeniable that smoking and using any forms of tobacco is bad for your health. And the rate of smoking cigarettes has been on the decline for years and years now. That said, a...
Here, 24/7 Wall St. has included a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates in February and March.
More and more branded drugs seem to be facing generic competition. The impact might not be so positive for Big Pharma giants, but this can be a serious victory for consumers and patients who are in...
Editas Medicine shares were crushed on Tuesday after the company announced that its president and chief executive, Katrine Bosley, would be stepping down from these roles effective March 1.