Topic:

Regulatory

Latest Headlines

Latest Headlines

Animal health companies not exempt from FDA marketing regs, either

The FDA issued Paris-based AB Science a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.

J&J partner Aduro grabs an FDA 'breakthrough' nod for its immuno-oncology combo

Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.

Seizures in horses in Kentucky focus attention on drug compounding

Former FDA associate commissioner Peter J. Pitts added his voice to calls for the need to regulate animal drug compounders who put together illegal animal drug combos, accusing the FDA of doing nothing while animals are dying from the practice.

FDA adds recalls API as openFDA initiative gathers pace

The FDA is continuing to push ahead with its openFDA initiative, with this week's rollout of an application programming interface (API) for recall data coming a month after its adverse event system went live. And the regulator plans to maintain the pace throughout the rest of the summer.

Top officials at FDA's India office bolt after less than a year

FDA Commissioner Margaret Hamburg has urged India's drugmakers and regulators to get on board with international quality standards, while promising close cooperation from its expanded office there. But efforts are being hampered by the exit of top officials.

China allows trial of investigators of GSK sex-tape scandal to go public

China has abruptly changed course on its plans to prosecute private investigator Peter Humphrey and his wife Yu Yingzeng in a closed trial. Now Humphrey and Yu, who were arrested last summer as part of China's investigation of bribery charges involving GlaxoSmithKline, will be tried in a public proceeding.

InterMune bags a 'breakthrough' nod of its own in a race with Boehringer

InterMune secured the FDA's breakthrough therapy designation for an in-development treatment for a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the U.S. market.

Salix wins FDA approval for a rare disease drug

Salix Pharmaceuticals picked up FDA approval for an orphan therapy, giving the company another revenue source as it plots a tax-saving move to Ireland.

Wearable biosensor for assessing back injuries wins FDA clearance

Australia's dorsaVi just received 510(k) clearance from the FDA for its wearable biosensor for assessing movement in the spine and lower back.

Salix scores another FDA green light with approval for angioedema med Ruconest

In its second FDA nod this week, Salix Pharmaceuticals won the go-ahead for Ruconest, its first-in-class treatment for a rare genetic disease, hereditary angioedema.