WASHINGTON – The first PDUFA clouds are forming as a revised version of the user fee package heads to the Senate floor this week for possible amendments and a vote.
Being the CEO of a U.S. biopharma company is a whole lot riskier these days as the FDA continues to keep its promise to hold corporate officials accountable for the off-label promotion activities of their companies and employees.
Honing in on one family that may hold the key to unlocking some of the secrets of Alzheimer's, Genentech Inc. has joined an international collaboration in a unique clinical trial that will open the door to shared research in hopes of finding a way to prevent the disease.
WASHINGTON – Drugmakers are keeping their fingers crossed as two separate bills to reauthorize PDUFA roll through Congress well ahead of its Sept. 30 expiration.
The second time proved to be a charm for Arena Pharmaceuticals Inc.'s lorcaserin as it sought a vote of confidence from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) in its benefit-risk profile as a weight-loss drug.
In a bit of a déjà vu, the FDA's Arthritis Advisory Committee (AAC) once again overwhelmingly rejected a sponsor's quest to expand the label of its IL-1 blocker to include the prevention of gout flares.
Whether Pfizer Inc. cleared the efficacy bar with tofacitinib, its first-in-class JAK inhibitor for rheumatoid arthritis (RA), will be open for debate at Wednesday's meeting of the FDA's Arthritis Advisory Committee (AAC).
WASHINGTON – Regeneron Pharmaceuticals Inc. is hoping Arcalyst can do what another IL-1 blocker couldn't do last year – wow the Arthritis Advisory Committee (AAC).
