Topic:
Regulatory
Latest Headlines
Latest Headlines
UPDATED: FDA tracking down new outbreak tied to compounded drug
Call it FDA déjà vu. While Congress continues to spar with the FDA over its oversight of compounding pharmacies, agency officials are running down yet another outbreak of possible infections tied to a potentially contaminated steroid manufactured by a compounding pharmacy.
Alexion snags latest 'breakthrough' coup with PhIII rare-disease drug
Already handed an orphan drug designation alongside fast-track status, the FDA has added the highly sought after "breakthrough drug" designation for the therapy, which could further shave some time off the development schedule.
Pharmaxis slashes staff after FDA red-flags cystic fibrosis treatment
The biotech says it will cut 48 jobs, or about a third of its workforce, as it gets ready to try to satisfy regulators with another study of the therapy, which is marketed in Europe.
FDA sticks 'deadly' tag on Cook's stent recall
The FDA has affixed its most serious warning to Cook Medical's recall of the Zilver PTX stent, warning that problems with the device's delivery catheter could lead to thrombosis, amputation or death.
FDA responds to one small piece of Avandia criticism
The FDA yesterday responded to a Forbes op-ed from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, published earlier that day. In it, Nissen railed the...
Novartis apologizes over Diovan study as probe shows employee involvement in trials
Novartis' blood pressure Diovan is on the wane as its expects generics next quarter to begin eating at its blockbuster status. But even as it comes under attack by generics, so does its reputation, as a probe by Novartis reveals that not everything in its trials in Japan followed accepted protocol.
Roche wins FDA approval for novel diabetes Dx
Roche won the FDA's blessing to market a hemoglobin-based diabetes diagnostic, the latest advance in testing for the disease and the first assay of its kind approved in the U.S.
Aveo shares shellacked after Astellas drops EU game plan on kidney cancer
Three weeks after an FDA panel overwhelmingly rejected Aveo's bid to gain an approval for its kidney cancer drug tivozanib, the biotech has earned another vote of no confidence--this time from its pharma partner.
Intuitive wins first da Vinci trial; stock jumps
Intuitive Surgical has prevailed in the first of at least 26 lawsuits over its da Vinci robotic surgery system, as a Washington jury found that the company was not negligent in its training of surgeons.
FDA ban could cost India's Wockhardt $100 million
An FDA import ban can be costly, and India's Wockhardt says the import alert it is now under could slice $100 million out of its revenues.
