A new granule formulation of Prograf (tacrolimus; Astellas) has been made available for the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, in combination with other immunosuppressants.
Drug overdoses resulted in approximately 72,000 deaths in the US, according to the CDC.
The FDA has granted marketing clearance for ClearMate (Thornhill Research), a device intended for use in an emergency room (ER) setting to help treat patients with carbon monoxide poisoning.
EyePoint announced the launch of Dexycu (dexamethasone intraocular suspension) 9% for the treatment of postoperative inflammation after cataract surgery.
Compared to placebo, treatment with ustekinumab resulted in a significantly greater proportion of adults with moderate to severe UC achieving clinical remission at week 44 (primary endpoint).
Alexion announced the publication of data from the phase 3 open-label extension of the REGAIN trial (ECU-MG-302) that assessed the long-term safety and efficacy of eculizumab (Soliris) for the treatment of adults with anti-acetylcholine receptor (AChR) antibody-positive refractory generalized myasthenia gravis (gMG).
Allergan announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application for ubrogepant, a highly potent oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults.
Eisai and Imbrium Therapeutics announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational insomnia treatment.
Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24…
ViiV Healthcare announced positive 48-week data from the phase 3 ATLAS (N=616) and FLAIR (N=566) studies evaluating a long-acting injectable formulation of cabotegravir + rilpivirine in patients with HIV-1 infection.
