The FDA has told Boston Scientific its Watchman implant designed to help prevent strokes in atrial fibrillation patients will have to face a third advisory panel before gaining approval.
Stellar Phase II data has helped Pfizer's breakthrough-designated meningitis B candidate surge ahead on its regulatory pathway to catch up with Novartis' Bexsero. And now, with the two companies submitting applications for approval on the same day, whether Pfizer's jab reaches the market first will be up to the FDA to decide.
As mobile medical apps and devices gain market traction, lawmakers are stepping up with questions about how to best regulate the devices.
Navidea Biopharmaceuticals secured the FDA's blessing to market Lymphoseek, its diagnostic aid, for use in head and neck cancer patients.
Novartis' Bexsero, approved in 34 countries, was the world's first marketed vaccine to protect against the deadly meningitis B. And now, it's one step closer to becoming the first in the U.S.--that is, if a Pfizer candidate doesn't beat it to the finish line.
On Tuesday, the FDA posted a warning letter sent last week to Chinese ingredientmaker Tianjin Zhongan Pharmaceutical listing problems with keeping equipment clean and running down problems.
Alere's i Influenza A & B test, which the company says is the first and only molecular test to detect and differentiate beween the two types, received FDA clearance on June 16.
In April, the FDA banned a plant in Bangalore, India, owned by Canadian generics maker Apotex. An FDA warning letter posted today explains why.
Both Pfizer and Novartis have picked up the FDA's much-coveted breakthrough-therapy designation for their meningitis B vaccines, and now the rivals have chosen the same day to submit their injections for approval, leaving it up to regulators which will hit the market first.
In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent last week and posted today by the FDA says that among other issues, it found that the company had deleted data of failed test results and then reported that the batches had passed.