Latest Headlines

Latest Headlines

FDA panel wants bone drugs' labeling changed, but how?

What to do about the potential risks of bisphosphonates? An FDA advisory panel wasn't exactly sure. At a meeting last week, the agency's expert committee voted to change the labeling on these popular

FDA panels to review bone drug safety

Should women using bone-building bisphosphonate drugs take a holiday from therapy to help avoid long-term side effects? Or should they limit use of the popular meds--such as Merck's ($MRK) Fosamax,

Roche keeps up DTC on Boniva while others cut

Marketing osteoporosis drugs has grown more complicated since Merck's Fosamax went off patent a couple years ago. Now that there are low-cost alternatives to branded bisphosphonate treatments,

Bone drugs get new fracture-risk warning

The FDA's review of bone-drug safety turned up enough evidence for a new warning about the risk of a rare-but-serious fracture of the thigh bone. There's been talk about a link between fractures and

Novartis, GSK meds get expanded indications

The FDA has approved Novartis' osteoporosis drug Reclast for an expanded indication. Currently approved as a once-yearly infusion to treat post-menopausal osteoporosis, the drug will now also be

FDA calls 'all clear' on bone meds

Bone drugs Reclast and Fosamax can step out from under a safety cloud, because the FDA came, saw and found nothing. The agency had been reviewing the two meds--sold by Novartis and Merck,

Novartis med gets nod for fracture prevention

SPOTLIGHT: Novartis med gets nod for fracture preventionNovartis said the FDA approved its bone-building drug Reclast as a treatment to prevent additional fractures following a hip fracture; the

FDA: Osteo meds can cause severe pain

Oh, the irony. The very drugs prescribed to strengthen bones can spark stabbing limb and joint pain, according to a reminder from the FDA. Info about the possibility of those pains--which can be

Novartis gains Aclasta, loses Prexige

From the good news, bad news file: Novartis got the EU's approval to sell its new osteoporosis drug Aclasta, known in the U.S. as Reclast. Reclast

ALSO NOTED: FDA to speed up generic approval; Genfit starts Phase II trials; and much more...

Could the steady trickle of generics approvals out of the FDA suddenly become a rapid stream? The agency is touting an initiative, called Generic Initiative for Value and Efficiency (GIVE), to speed