Topic:

Regulatory

Latest Headlines

Latest Headlines

Data in hand, Merck shoots for Keytruda approval for lung cancer

Hot on the heels of Bristol-Myers Squibb, Merck announced over the weekend that it has filed for FDA approval to market its PD-1 star Keytruda for non-small cell lung cancer.

FDA approves new device for surgical sealing during cranial procedures

The FDA approved HyperBranch Medical Technology's Adherus AutoSpray Dural Sealant to provide watertight closure during cranial procedures, according to a March 30 approval letter. Approval came via the stringent PMA pathway, which included a clinical trial, after which Adherus was deemed noninferior to Integra LifeSciences' surgical sealant system.

Second OTC drug recall within a week in Taiwan

Taiwan drug authorities issued their second drug recall within a week for use of lower-grade ingredients in over-the-counter drugs, this time targeting 23 products of 19 Taiwan companies.

AdvaMed supports Senate move to speed along free trade agreements with Asia, Europe

Democrats and Republicans just agreed to send "fast track" Trade Promotion Authority legislation to the Senate for a vote. Granting the president fast-track authority allows Congress to vote on free trade agreements on a yes, no basis; if passed, Congress would not have the authority to make amendments to the agreements.

Animal testing hits China social media with clothesline cats

This may be why your mother told you never to air your dirty laundry in public: there's an uproar in Beijing over the bodies of six dead cats hanging on a clothesline outside Macro-Union Pharmaceutical.

Alcon intraocular lens gets FDA's stringent PMA approval

Novartis' Alcon received FDA approval for its implantable AcrySof IQ ReSTOR +2.5 Diopter intraocular lens, enabling vision correction at all distances in eye care patients with or without presbyopia who undergo cataract surgery.

Roche, Novartis to halt marketing for unreimbursed cancer drugs in Australia

Swiss drugmakers Roche and Novartis Oncology have told Australia to go fly a kite if it expects a company to market a cancer drug in the country without Pharmaceutical Benefits Scheme coverage. The two companies announced their boycott intentions ahead of a Monday hearing by a panel of Australia's Senate.

FDA coordinates with pharma to address IV fluid shortage

The FDA's Center for Veterinary Medicine announced on April 13 that it has a plan in place to address a shortage of IV fluids used to treat large animals. The shortage of three-litre and five-litre doses has been caused by a combination of increased demand and decreased production, according to a statement from the FDA. 

UN restrictions on narcotic ketamine would impede veterinary practices, trade group argues

Ketamine, the narcotic known to many addicts as Special K, is in the crosshairs of the United Nations, which was planning a hearing to discuss whether it should be internationally regulated as a schedule I substance, right along with such forbidden drugs as LSD. Such strict regulation would be a problem for veterinarians, however, because they use ketamine as an anesthetic to treat both large and small animals.

Medicines Co.'s cangrelor finally lines up for FDA approval

A panel of FDA advisers reversed its earlier derision and voted in favor of The Medicines Company's long-delayed blood thinner, spelling a likely approval for the drug after years of setbacks.