The U.S. Food and Drug Administration has given a temporary thumbs up to Ebola test FilmArray BioThreat-E from BioFire Defense, a bioMérieux company. The test offers results in one hour rather than the one to two days required by existing methods.
St. Jude Medical snagged FDA approval for its next-generation ablation catheter for atrial fibrillation, bolstering the company's presence in a growing electrophysiology market and strengthening its footprint in the cardiac rhythm management sector.
FDA's final guidance on medical device recalls and associated reporting requirements omits the most pernicious proposal of the draft guidance, but is of little utility and "will probably soon be forgotten," according to the FDA Law Blog, written by Hyman, Phelps & McNamara attorneys.
Novo Nordisk says the U.S. Attorney in Massachusetts has subpoenaed it for information about potential manufacturing issues at a plant in Kalundborg.
Following a meeting with regulators in September, Sarepta spelled out a new set of data that the FDA is looking for in the application for its closely watched Duchenne muscular dystrophy drug eteplirsen, and the biotech says it will have to delay filing--another dramatic turning point for the company this year, which saw its shares plunge 30% on the news this morning.
With the goal line for lung cancer in sight at the FDA as it races with an ambitious R&D team at Bristol-Myers Squibb, Merck has grabbed bragging rights to the agency's breakthrough drug designation for the checkpoint inhibitor pembrolizumab (Keytruda) for that golden market opportunity.
Denmark-based Novo Nordisk said on Friday that it had received a subpoena from a U.S. Attorney who wants some info about its manufacturing operations at a plant in Kalundborg. But the company said it really has no idea why.
Baxter widened its hemophilia franchise on the eve of its breakup, winning FDA approval for a drug that treats a rare form of the bleeding disorder.
An FDA committee of experts this summer voted overwhelmingly against approval of AstraZeneca's new ovarian cancer treatment. But reviewers for the EMA gave it a nod for use on patients with platinum-sensitive ovarian cancer and BRCA mutations, FierceBiotech reports.
European regulators have recommended an early approval for AstraZeneca's new ovarian cancer treatment, welcome news for the company as it defends rosy sales estimates for its oncology pipeline.