Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA tightens reins on equine compounding companies

The FDA continues to tighten the reins on animal drug compounding, most recently by sending three companies warning letters targeted at equine products they allegedly marketed without first getting regulatory approval.

FDA advisers spurn Novartis' blood cancer drug, putting approval in doubt

Novartis' new multiple myeloma is treatment too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the cancer drug next year.

Spark snags a 'breakthrough' tag for its Phase III gene therapy

Gene therapy startup Spark Therapeutics has picked up the FDA's coveted breakthrough-therapy designation for its lead candidate, a one-time treatment that promises a permanent solution some rare eye diseases.

Dexcom snags FDA approval for next-gen artificial pancreas tech for blood glucose monitoring system

As med tech outfits race to develop innovative, noninvasive technology for diabetes monitoring, Dexcom snagged FDA approval for a new artificial pancreas algorithm for its continuous glucose monitoring device.

Valeant labeling snafu affects Sanofi's Aplenzin, as well as Valeant's vaseretic

The 206,000 bottles of blood pressure medication vaseretic that Valeant has been recalling is not the only product affected by a packaging snafu that resulted in outdated package inserts. The drugmaker has also been retrieving 19 lots of the antidepressant Aplenzin that it makes for Sanofi.

Aeterna Zentaris bottoms out after a stinging FDA rejection

The FDA has rejected Aeterna Zentaris' orphan treatment, taking serious issues with its pivotal data and further battering the foundering biotech's share price.

FDA resumes its long search for a CIO

The FDA resumed its active search for a CIO late last month, more than one year after it first advertised the position, Regulatory Focus reports.

Ranbaxy manufacturing mess costs it approvals for Nexium, Valcyte

Ranbaxy said today that the FDA has withdrawn its 6-month exclusivity for Valcyte. It also said it had lost its tentative approval for AstraZeneca's heartburn blockbuster Nexium. Nexium went off patent in May and Valcyte went off patent last year.

Sanofi, Protein Sciences win flu jab nods in older adults

A couple of flu vaccine makers have new patient populations to target, thanks to a pair of recent FDA approvals in older adults.

Government report says medical device tax will not deter innovation

The Republican takeover of the Senate means the chances of a repeal of the medical device tax are improved, but the Congressional Research Service just gave supporters of the tax ammunition. This week it released to the public a report claiming the medical device tax will only result in a 0.2% decrease in device industry jobs and output.