BLA
12-23-2008 |
12:05 hs.
Amgen Inc announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration to market denosumab, for treatment and prevention of postmenopausal osteoporosis (PMO) in women. The application also covers treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer
09-30-2008 |
12:08 hs.
French drugmaker Ipsen announced the U.S. Food and Drug Administration would not be completing the first-cycle review of its new drug Dysport, indicated for the treatment of patients with cervical dystonia. The review has been extended to no later than December 28th.
09-24-2008 |
18:10 hs.
Likely to be delayed by some two months
09-05-2008 |
13:23 hs.
Head and neck cancer drug
09-02-2008 |
18:20 hs.
As pre-pandemic immunization against global flu
06-16-2008 |
12:20 hs.
Novartis AG has withdrawn its biologic license application (BLA) to market Aflunov pandemic influenza vaccine in Europe, the European Medicines Agency (EMEA) reported. The giant Swiss drugmaker said it could not supply the European regulators with additional required data in the timeframe requested.
05-06-2008 |
11:46 hs.
03-20-2008 |
19:41 hs.
in Aesthetic indications
03-17-2008 |
09:33 hs.
