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.
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.
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.
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.
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.
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.
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.
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.
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.
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.