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The agency issued a complete response letter (CRL) to Lundbeck and its Japanese partner Takeda Pharmaceutical declining to expand the drug’s approval to treat various aspects of cognitive

The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of Nuplazid outweighed the risks of treatment. The FDA

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the management

The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016. Aralez CEO Adrian Adams said: "The acceptance of our NDA for

The trial, conducted in collaboration with the EU-sponsored UNISEC consortium, is designed to evaluate the safety and immunogenicity of M-001 when used ahead of an avian influenza vaccine.

Under the license, ABBA will be able to use the OmniRat, OmniMouse and OmniFlic platforms to generate fully human mono- and bispecific antibodies. Ligand is to receive an

Ubenimex is an oral, small-molecule, dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase (LTA4H), the enzyme which catalyzes the committed step in the formation of the pro-inflammatory mediator, LTB4.

Bendeka (bendamustine hydrochloride injection, or bendamustine HCI) is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride. It was approved in December last year

The research collaboration will integrate Forge’s expertise in metalloenzymes with Active Motif’s knowledge in epigenetics and related technologies. Under the alliance, the companies intend to validate emerging epigenetic