W.L. Gore's has achieved a broader FDA approval for its endovascular graft-repair device.
Roche's Ventana Medical Systems arm gained pivotal Chinese regulatory approval for a companion diagnostic that pairs with Pfizer's targeted lung cancer drug Xalkori.
The Waltham, MA-based biotech won the BTD for entinostat, an experimental histone deacetylase inhibitor (HDACi) set to begin Phase III testing in early 2014 in combination with exemestane in postmenopausal women with metastatic ER-positive breast cancer who have progressed on hormonal therapy.
Testing giants Quest Diagnostics and LabCorp have been gouging Virginia's Medicaid system, according to a lawsuit, inflating prices by as much as 1,000% of what they charged private insurers.
By Michelle Rohrer, Vice President, U.S. Regulatory Affairs, Genentech In August I had the pleasure of participating in Fierce's "Understanding Major Regulatory Change" webinar. This...
Diagnostics giant Dako got an earful from the FDA over how it manufactures test kits at a Denmark plant, including the company's high-profile companion diagnostic for Roche's blockbuster Herceptin breast cancer treatment.
When OvaScience went public last year, the management laid out the tantalizing prospect that their lead fertility program could deliver a marketable product by the end of this year. And they could do it, according to their S-1, without the risk associated with FDA oversight for a new drug by developing it as a cellular and tissue-based product.
Dako got hit with an FDA citation over what the agency says are quality system manufacturing violations involving one of its signature breast cancer diagnostic kits and other related products.
GlaxoSmithKline and Theravance have nailed down a solid majority of FDA panel votes in favor of marketing their new COPD therapy Anoro Ellipta. The outside experts voted 11 to 2 this afternoon to endorse the therapy, opening the door to the first of several new drug that will likely wind up duking it out in a tough fight for market share.
Hospira, which jumped early into the the biosimilar market in Europe, has seen its efforts pay off with the approval of Inflectra, a biosimilar of Johnson & Johnson's Remicade.