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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
Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment. Read More
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More
A California appeals court has reinstated a $6.5 million jury award against Takeda in a case involving its diabetes drug Actos, which announced in April that it would pay up to $2.4 billion to settle the majority of U.S. lawsuits involving the therapy. Read More
The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS. Read More
In a document released Friday, the Senate Appropriations Committee calls for fiscal year 2016 user fee amounts totaling nearly $1.2 billion for drugs and biologics — figures that are in line with those proposed by its counterpart in the House. Read More
Paris-based AB Science, a developer of tyrosine kinase inhibitors, received an FDA warning letter for failing to report adverse events promptly and lapses in clinical trial monitoring. Read More