Topic:

Regulatory

Latest Headlines

Latest Headlines

AstraZeneca grabs a surprise early approval for its $2B cancer contender

Despite loud objections from its advisers, the FDA granted an accelerated approval to AstraZeneca's ovarian cancer treatment, clearing an oral therapy the U.K. drugmaker believes will bring in blockbuster sales.

Novo Nordisk gets EU recommendation for Tresiba use in kids

Novo Nordisk has a while yet to wait for another shot at FDA approval for Tresiba, a drug on which it has pinned its future, but it continues win support for it in Europe.

Private equity firm backs Sonoma Orthopedic with $12M to get ankle implant to market

Chicago-based private equity group First Analysis expects its $12 million cash infusion into Sonoma Orthopedic Products will be sufficient for the startup to gain FDA clearance for a new ankle implant--as well as to launch it and start to scale up sales.

Orexigen's weight-loss drug gets thumbs-up from CHMP

Orexigen has scored another big boost for its weight-loss drug, with a European drug advisory group giving it a recommendation for approval. The favorable review comes three months after the FDA approved it in the U.S., where it is already seeing some significant demand.

Sorin says newly cleared Memo 3D ReChord will improve mitral valve repair

Italy's Sorin Group says its just-cleared Memo 3D ReChord semirigid annuloplasty ring for mitral valve repair will simplify the procedure and enable surgeons to achieve reproducible results.

Small cap Cerus spikes on back-to-back Intercept approvals by FDA

Small cap Cerus has gained some serious ground on Wall Street after the FDA approved its Intercept Blood System for platelets just a few days after the agency approved it for plasma use. Investors are betting that with the risk of Ebola in the forefront of public consciousness that processors of blood products will use any technology they can to improve the safety of their supply. These approvals mark the first time the FDA has approved a system to inactivate pathogens in platelets or plasma.

China promises faster drug approvals, equal treatment for U.S. companies

U.S. and Chinese trade officials announced on Thursday that China will streamline drug approvals and promised equal treatment of U.S. and Chinese companies in pricing probes.

FDA outlines UDI implementation plans for 2015

The FDA outlined its 2015 plans for Unique Device Identification. If successfully pulled off, the UDI system promises many benefits to companies and consumers, including improved device recalls and better evidence collection.

FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring

The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.

AstraZeneca snags EU approval for first-in-class cancer fighter Lynparza

AstraZeneca scored European approval for its ovarian cancer-treating drug Lynparza (olaparib), expanding its cancer portfolio at a time when the company is trying to show investors that it's better off independent.