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The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the supplemental New Drug Application (sNDA) currently under review

 This approval allows for the marketing of Xermelo® (telotristat ethyl) in the above indication in all 28 member states of the European Union, Norway and Iceland. David Meek,

The FDA has approved fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or Trelegy Ellipta as a long-term, once-daily and maintenance treatment for patients with COPD, including chronic bronchitis and emphysema. Trelegy Ellipta

The New Jersey-based drug contract manufacturer will pay $750m at the time of closing of the transaction. It will pay the remainder amount in interest-free equal installments over

Orphan designation grants special status to a drug or biologic under development to treat a rare disease or condition and qualifies the sponsor of the product for various

The Ultragenyx offer represents a premium of over 358% to Dimension's unaffected share price as of August 24, 2017 and premiums of 24% and 48% over the implied

The cancer drug was evaluated in the late-stage study dubbed MURANO in combination with MabThera/Rituxan (rituximab) in CLL patients whose disease had relapsed or is in the refractory

The company signed two sale agreements to generate total proceeds of $2.48bn. Under the first deal, CVC Capital Partners Fund VI will acquire Teva’s women’s health product portfolio across contraception, fertility,

Proposed to have a brand name of Trelegy Ellipta, FF/UMEC/VI has been recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP) in