FDA

FDA Articles

Teva Pharmaceutical announced on Monday that the FDA approved the first generic equivalent to Nexium delayed-release capsules in the United States.
GW Pharmaceuticals reported top-line results from the first of three Phase 3 trials for Sativex.
What are investors, and patients, supposed to think when is launching a generic version of Diovan?
Analysts are beginning to make their calls for what the future will hold for Gilead Sciences, AbbVie and Express Scripts.
AbbVie and Express Scripts have entered into an exclusive agreement under which Express Scripts will distribute AbbVie's hepatitis treatment.
A biosimilar application filing from Apotex has been accepted by the Food and Drug Administration for version of Amgen's Neulasta.
While this was generally a known event coming down the pipe, arthritis drug Celebrex now has a generic competitor in America.
Array BioPharma has announced that it had reached a definitive agreement with Novartis to regain full worldwide rights to cancer drug binimetinib.
Avanir Pharmaceuticals announced that it has entered into a definitive agreement with Otsuka Pharmaceutical for a $17.00 per share buyout.
On Monday, Sunesis made an announcement that it would be making a presentation regarding its drug candidates vosaroxin and cytarabine.
Geron hasannounced that it entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech to develop and commercialize imetelstat.
The FDA gave Geron some good news Monday morning when it removed the clinical hold on the its investigational new drug application for imetelstat.
Durect and Pain Therapeutics have been stung by Pfizer's decision to discontinue to develop Remoxy.
Sarepta Therapeutics shares took a big hit on Monday morning as disappointing news started its week out on the wrong foot.
Alcobra recently posted news of an FDA trial and its shares traded down about 50% Monday morning.