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"This positive opinion underlines two things", explains Dr. Henri Huttunen, Chief Scientific Officer of Herantis. "First, there is a dire need for novel treatments for ALS, which is

The reduction includes approximately 90 positions in the U.S. and Europe. No customer-facing positions within ARIAD’s commercial or medical affairs organizations are included in this action. This reduction

The initial focus of the JV will be immediately advancing ProscaVax, OncBioMune’s novel prostate cancer vaccine combining a tumor-associated antigen with biological adjuvants, into a Phase 2A/2B clinical

The US District Court for Southern Florida ruled that Allergan’s subsidiaries Watson Pharma and Watson Laboratories had infringed on two claims of the Lialda drug patent. Shire senior

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.