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FDA/Panel Decisions

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fdanotapproved-feb15.jpg Shares of Motif Bio plc (MTFB) plunged as much as nearly 75% today to touch a new low of $2.61, following disappointing regulatory news.

British drug maker AstraZeneca Plc (AZN.L, AZN) announced Wednesday that the US Food and Drug Administration or FDA has granted Orphan Drug Designation or ODD to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome or HES. The company noted that HES is a group of rare, potentially...

British drug maker AstraZeneca Plc (AZN.L, AZN) and its biologics research and development arm, MedImmune, announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation for MEDI8897, a next-generation preventive medicine for respiratory syncytial virus or RSV. Separately,...

Merck & Co. Inc. (MRK), said Wednesday that V114, the company's investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease or IPD caused by the vaccine serotypes...

Dr. Reddy's Laboratories Ltd. (RDY, DRREDDY) and its subsidiary, Promius Pharma, LLC announced late Sunday the approval of TOSYMRA, previously known as DFN-02, by the U.S. Food and Drug Administration. TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA...

Vertex Pharmaceuticals Inc. (VRTX) announced Monday that the European Commission has granted approval of the label extension for ORKAMBI (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis or CF aged 2 to 5 years old who have two copies of the F508del mutation, the most common form...

Genentech, a member of the Roche Group (RHHBY), said Thursday that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Tecentriq (atezolizumab) in combination with Abraxane (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for...

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