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
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
A newly published article in Nature Methods describes CDI Laboratories' participation in the NIH Protein Capture Reagents Program (PCRP... read more