Topic:

Regulatory

Latest Headlines

Latest Headlines

One-hour Ebola test from bioMérieux receives FDA emergency use authorization

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 snags FDA approval for next-generation ablation catheter

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.

Attorney: FDA final guidance on product recalls not helpful

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guidance on medical device recalls and associated reporting requirements omits the most pernicious proposal of the draft guidance, but is of little utility and "will probably soon be forgotten," according to the  FDA Law Blog, written by Hyman, Phelps & McNamara attorneys.   

U.S. Attorney asks Novo Nordisk about plant in Denmark

Novo Nordisk says the U.S. Attorney in Massachusetts has subpoenaed it for information about potential manufacturing issues at a plant in Kalundborg.

UPDATED: Sarepta plunges as CEO moves goal line on Duchenne MD drug downfield

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.

Merck grabs another 'breakthrough' in PD-1 lung cancer race with Bristol-Myers

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.

U.S. Attorney subpoenas Novo for info on Denmark plant

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 wins FDA approval for another hemophilia drug

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.

EMA favors AstraZeneca's ovarian cancer drug Lynparza that FDA committee dissed

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.

AstraZeneca gets some EU encouragement for its $2B cancer hopeful

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.