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Bristol-Myers Squibb has received breakthrough therapy designation from the FDA for its first-in-class investigational BMS-663068 compound for use in preventing HIV infection. Read More
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
Exelixis’ Cometriq improved patient outcomes in a pivotal Phase 3 trial for metastatic kidney cancer — signaling new life for the drug, which failed another study last fall. Read More
Regulators in the EU have cleared the way for Amgen to market its cholesterol-lowering drug Repatha, marking the world’s first approval of a PCSK9 inhibitor. Read More
Oncology drugmaker Delcath Systems has received orphan drug designation for melphalan to treat intrahepatic cholangiocarcinoma, or ICC, a cancer of the bile duct that arises within the liver. Read More
Insects found in IV solutions have forced Baxter International to voluntarily recall two lots of product, the firm’s seventh recall of an intravenous solution since December 2013. Read More
Venture capitalists invested roughly $2.3 billion in biotechnology companies in the second quarter of 2015, up 32 percent from the prior quarter — the largest quarterly investment in the sector since PwC began issuing its quarterly MoneyTree Report two decades ago. Read More
In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug. Read More