WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food […]
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Latest Approval Expands Product Label in Canada and Further Strengthens Global Brand for Once-Daily, Dual Mechanism Antibiotic DUBLIN, IRELAND–(Marketwired – Jul 23, 2015) – Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance […]
Recently, Vertex received approval for a new two-drug therapy called Orkambi, designed to treat 8,500 cystic fibrosis patients over the age of 12 who have the most common mutation for […]
Update: This morning, Bristol-Myers Squibb announced that its immunotherapy, Opdivo, also delayed cancer progression more than Afinitor in kidney cancer. This raises questions about the sales potential of Exelixis’ drug. […]
The European Commission approval is based upon Phase III clinical trial – Reyataz®(atazanavir) and cobicistat combination demonstrated virologic failure rates as low as 6% at 48 weeks and 8% at […]
BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals has launched four new products since June 2015. On July 13, the company obtained FDA approval for its tobramycin inhalation solution (a generic equivalent for Tobi® […]
UnitedHealth Group (UNH), buoyed by growth potential of its expanding pharmacy benefit business, raised its earnings outlook with the coming addition of a much larger drug management operation. The nation’s […]
TOKYO & VALBY, Denmark–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved REXULTI® (brexpiprazole) as an adjunctive therapy […]
The Food and Drug Administration strengthened its safety warnings about heart-attack and stroke risks linked to a class of common pain relievers that includes medicines such as Celebrex, Advil, Motrin […]
It used to be that the major hurdle in getting a new drug approved was successfully completing phase 3 trials – the long-term studies needed to prove to regulators that […]