The FDA clears Eliquis ( apixaban ) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction
Aug 21 (Reuters) - Bristol-Myers Squibb Co and Pfizer Inc on Thursday said U.S. regulators have approved an expanded use for their Eliquis blood clot preventer, to treat blood clots in the legs and...
Ebola drug, TKM-Ebola, was being tested on animals under the FDA ’s “Animal Rule”. While this is an accurate statement, a ..... Government Agency Efficacy testing conducted on animals under FDA ’s Animal Rule regulatory guideline Phase 1 safety trial on
Aug 21 (Reuters) - Bristol-Myers Squibb Co and Pfizer Inc on Thursday said U.S. regulators have approved an expanded use for their Eliquis blood clot preventer, to treat dangerous blood clots in the legs and lungs.
image quality, faster 3D image acquisition and improved ease-of-use and workflow during surgical procedures using intraoperative MRI. The FDA cleared the advancements in February 2014 and the EC cleared them last month. Post your comment!
Soon Movantik, Nektar's PEGylated naloxol (also known as NKTR-118) has less than a month to go before it should receive FDA approval. This oral opioid antagonist has shown statistically significant efficacy versus placebo in multiple studies of opioid
The FDA clears Intuitive Surgical's ( ISRG +1% ) Firefly Fluorescence Imaging feature that is used with the da Vinci Si System. Previously
of Ampion, the firm questions whether it should use the data in its BLA submission. The company has apparently contacted the FDA for guidance on the issue. Coincidentally, Ampio just happens to have a solution to the problem. It has 6-week interim data
Aug 21 (Reuters) - Biofrontera AG : * Says pre-NDA meeting scheduled with FDA for the approval of Ameluz and BF-RhodoLED * Says has scheduled the pre-NDA (new drug application) meeting for 8 October
unmet medical indications in neurology and oncology. The strategy should improve the success rate at the Food and Drug Administration , which has become exceedingly risk-sensitive to new drugs in well-treated areas such as cardiology