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The FDA advisory panel voted 6:1 in favor of the investigational antibody-drug conjugate. ODAC with its voting affirmed that the results of the phase 3 ALFA-0701 trial showed

Based on a series of discussions with and written communication received from the FDA, the Agency has informed Amicus that it may now submit an NDA for migalastat.

This new partnership builds on biology insights in the field of transcriptional regulation from the work of Prof. Matthias Geyer at the Max Planck Institute of Molecular Physiology

The deal will also include an additional payment of up to $100m based on the achievement of certain milestones.   Founded in 1983 and based in Meriden, Protein

FDA has also accepted sNDA for powder for oral suspension (PFOS) formulation of Sprycel. The sNDA has been submitted based on data from CA180-226, which is an ongoing phase

The mean Tmax of SequestOx was 4.6 hr with a range of 0.5 hr to 12 hr and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr with

The pharma company had filed a lawsuit alleging that Teva Pharmaceutical subsidiary Actavis’ alternative salt forms had directly infringed the Alimta vitamin regimen patent in the UK, Spain,

Under the terms of the agreement, Shield will continue to manage all regulatory aspects of Feraccru's initial marketing authorisation and planned future label expansion, supply product as well

The global and multicenter program will assess the safety and efficacy of fitusiran in three separate trials, including patients with hemophilia A and B with or without inhibitors