Thermo Fisher is plodding along with its blockbuster agreement to trade $13.6 billion for competitor Life Technologies, picking up European Commission approval on the condition that it sheds a few business units.
Ten years after BTG weathered a tempest as the FDA erected a barrier to its new treatment for varicose veins, the British biotech company has finally gained U.S. approval for its product and confidently predicts it can register peak sales of $500 million a year.
Hospira's long-troubled infusion pump business is dealing with another recall, earning the FDA's most severe warning over a device malfunction the agency said can lead to serious injury and death.
The FDA did a hard about-face today on GlaxoSmithKline's diabetes drug Avandia, deciding that the drug presents no more heart risk than the most commonly used Type 2 diabetes drugs and withdrawing the label warnings and other restrictions.
Johnson & Johnson and its partner Medivir won a green light from the FDA late on Friday to begin marketing their hepatitis C drug simeprevir, which will now be sold as Olysio.
Boston Scientific won FDA approval for yet another next-generation drug-eluting coronary stent system and has immediately ramped up its marketing machine to pursue new sales.
Direct-to-consumer DNA testing outfit 23andMe has run afoul of the FDA, and the agency served up a warning letter demanding that the company take its genetic screens off the market until it gets the proper clearance.
Novo Nordisk won the endorsement of a key European regulatory committee for a device designed to work in tandem with a Roche insulin pump to help simplify treatment for diabetics. A CE marking is likely and could open lucrative doors for both companies.
The creation of the new site follows a surge in visits by people using mobile devices. Almost 1-in-4 visitors to FDA.gov now uses a mobile device.
While the recent hack of FDA databases raised plenty of questions about its cybersecurity policies, the agency offered few answers. If a damning new report into government-wide practices is in any way representative of the FDA though, the agency will need to tighten up.