Prior to today's announcement, Alkermes management appeared confident in the data supporting the approval of ALKS 5461. Alkermes had planned for the company to grow its salesforce by as much as 70... read more
Prior to today's announcement, Alkermes management appeared confident in the data supporting the approval of ALKS 5461. Alkermes had planned for the company to grow its salesforce by as much as 70... read more
Alkermes today announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461, a once-daily, oral... read more
Eisai Submits Supplemental New Drug Application (sNDA) to FDA for FYCOMPA (perampanel) Pediatric Indications
Eisai Inc. announced Friday (3/30/18) that it has submitted a supplemental New... read more
Today the FDA announced that the agency has determined that the site cafepharma.com is in fact a drug and will require the company to submit a full new drug... read more
DotLab announced the results from a new study showing that its endometriosis test, which aids in diagnosing the disease, has the potential to also be used to monitor disease progression and... read more