Tag:
FDA approval
Latest Headlines
Latest Headlines
J&J gets FDA green light for blockbuster blood thinner Xarelto
J&J has scored another big regulatory win, gaining FDA approval late on Friday for Xarelto, a blood clot prevention therapy that has been tapped as one of the drug company's top six new drugs for
Novartis wins FDA OK of low-dose COPD therapy
Two years after the FDA originally stiff-armed Novartis on indacaterol inhalation powder regulators finally gave the COPD treatment a green light at a low dose. Word of the approval spread late on
As Ph3 failures spike Big Pharma hits the brakes on R&D spending
Just in time for BIO's big international confab that begins today in Washington D.C., Thomson Reuters has sized up the industry's dwindling appetite for massive R&D operations. And it's come up
FDA looking for advice on regulating nanotech
Nanotechnology is an important driver of new drug-delivery technology, but much of the nanotech research you read about on FierceDrugDelivery is still very much in the lab, with less than a handful
Acura shares spike on FDA painkiller approval, $20M Pfizer milestone
Acura Pharmaceuticals' two-and-a-half year saga to get a new opioid painkiller approved by the FDA has finally been capped with success. Late Friday the agency quietly handed out an approval for
Study: FDA beats EMA on new cancer drug approvals
It's a common belief among physicians and cancer patients that Europeans usually get the first shot at a new oncology drug, with Americans often waiting a considerable spell before the FDA follows up
Roche's Herceptin sensitivity test wins FDA nod
The FDA has approved a genetic test made by Roche's Ventana Medical Systems unit that more easily identifies ideal candidates for its breast cancer treatment Herceptin. Report
FDA provides conditional OK for GSK/Valeant's epilepsy drug
GlaxoSmithKline's ( $GSK ) $820 million gamble on Valeant's ( $VRX ) epilepsy drug Potiga (ezogabine in the U.S. and retigabine elsewhere) has paid off with an FDA approval that could pave the way to
UPDATED: FDA gives Optimer key antibiotic approval
There's going to be a lot of backslapping at barbeques in San Diego this weekend. The FDA sent out word this afternoon that it's approved San Diego-based Optimer Pharmaceuticals' ($OPTR) antibiotic
FDA approves mega-blockbuster Vertex hep C drug Incivek
Right on its PDUFA deadline the FDA announced that it has approved Vertex's blockbuster hepatitis C treatment Incivek, better known in the trade as telaprevir . And regulators were quick to bill the
