Top Regulatory News Stories – Week Ending July 19, 2019

Cellectar Biosciences announced the FDA has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). Dicerna Pharmaceuticals announced that the FDA has granted a Breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1). Neurocrine Biosciences said the FDA[…]

Regulatory Roundup: Top News Stories – Week Ending June 9, 2017

Here are the top nine regulatory news stories this week: The European Commission (EC) approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-based therapy. Full Story Here Gilead Sciences plans to submit a new triple combination HIV therapy for FDA approval[…]

Regulatory Roundup: Top News Stories – Week Ending May 12, 2017

There has been a lot of big news in the industry this week and here are some of the key regulatory highlights: The U.S. Senate confirmed Dr. Scott Gottlieb as the next commissioner of the FDA. Gottlieb, 44, served as an FDA deputy commissioner during the George W. Bush administration. He has also worked as a[…]

Regulatory Roundup: Top News Stories – Week Ending May 5, 2017

  This has been another exciting week with a flurry of regulatory activity in pharma and biotech. The FDA approved Radius Health’s drug TYMLOS to treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies.  However, this included a “black box” warning that the treatment had increased the[…]