The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.
When the FDA came through with their expected approval for Keryx's ferric citrate (formerly Zerenex), a new treatment to deal with complications of kidney disease, on Friday, a label warning that the drug could wind up triggering iron overload dampened analysts' enthusiasm for this treatment considerably, with Keryx's stock price ending Friday down 5%.
Hot on the heels of its FDA approval, a new combo pill from the HIV-focused partnership of GlaxoSmithKline and Pfizer, has won approval in Europe. ViiV Healthcare said that the EU had given a green light to its once daily combo pill Triumeq, an approval that will help it reach the $5 billion in peak sales it has been forecast to capture.
OncoMed is moving on from tandem setbacks in its cancer pipeline now that the FDA has removed its final clinical hold on one of the company's oncology candidates, clearing it to resume enrollment in a Phase I study.
It is not often that drug company employees get hauled off an airplane leaving the country and arrested. But it is not often that a drug company's products are tied to the deaths of dozens of people, like the compounded steroids that are believed to have given more than 750 people fungal meningitis in 2012.
OncoMed is moving on from tandem setbacks in its cancer pipeline now that the FDA has removed its final clinical hold on one of the biotech's oncology candidates, clearing it to resume enrollment in a Phase I study.
Merck has won the frenzied race to secure the first FDA approval for a new breed of cancer treatment, clearing the way for a U.S. launch and a scramble for dominance in a field expected to peak at nearly $35 billion a year.
Merck has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections.
Despite its well-publicized rejections of several high-priced cancer drugs, the U.K.'s National Institute for Health and Care Excellence has just recommended what's widely considered to be the most expensive drug in the world--Alexion's Soliris.
Wockhardt has been in a world of hurt since the FDA last year banned two of the plants that made drugs for the U.S. market. But the Indian drugmaker has said that with the help of outside consultants it can get most of its problems with the FDA resolved within the year, and that has the M&A handicappers suggesting it is prime takeover target.