Topic:

Regulatory

Latest Headlines

Latest Headlines

Baxter recalls a dialysis product due to mold

Baxter International, which has had ongoing contamination issues with some of its intravenous products, is now recalling one lot of a peritoneal product used on dialysis patients. It says the lot is contaminated with mold. The announcement, also sent out by the FDA, says there have been adverse reactions reported.

Plant issues cost Lilly, Boehringer Ingelheim a drug approval

The FDA has held off approval of a new Eli Lilly diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.

Lilly's end of the road on Evista looms with FDA nod for Teva generic

Eli Lilly is staring down the barrel of its Evista patent expiration. And Tuesday, Teva Pharmaceutical Industries won FDA approval to load the bullet. The company's generic version of Lilly's breast cancer and osteoporosis drug got the green light, and Teva says it will hit the U.S. market within a month.

UPDATED: FDA rejects Eli Lilly's SGLT2 diabetes drug empagliflozin

The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.

Amarin sues AstraZeneca ahead of launch of Vascepa competitor

Amarin's lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AzstraZeneca, which is awaiting FDA approval on its own product for treating super-high cholesterol.

The FDA will mull Navidea's latest pitch to widen the use of its injectable cancer imaging agent

The FDA has accepted Navidea Biopharmaceuticals' latest supplemental new drug application to expand the use of its Lymphoseek injectable diagnostic imaging agent to track more kinds of cancers.

AstraZeneca looks to pen injector approval to turn Bydureon diabetes sales around

AstraZeneca won U.S. approval of its Bydureon pen for once-weekly treatment of Type 2 diabetes. The pen will be the first of its kind to hit the market. The prefilled, single-use pen injector delivers microspheres that house exenatide, which is slowly released for better glycemic control.

GE Healthcare hit with FDA recall for infant warmer resuscitation systems

The FDA slapped GE Healthcare with a Class I recall--its most serious designation--for its infant resuscitation devices after the company found that malfunctions in the product could cause death.

Why does Alexion's Soliris cost $500K-plus? U.K. gatekeepers want to know

It's fairly routine for the U.K.'s cost-effectiveness watchdogs to ask companies for more data to support approval for use by the country's National Health Service. Clinical data, price modeling, the works. But asking for information on R&D costs? That's something different altogether.

Oxygen Bio shares soar after FDA lifts hold on brain injury drug

Shares of Oxygen Biotherapeutics shot up 30% Tuesday morning after the Morrisville, NC-based biotech announced that the FDA had lifted a clinical hold on Oxycyte, an experimental drug the military has been supporting as a possible treatment for traumatic brain injury.