fda approval

Novartis Halts Two Drug Development Programs

Swiss pharmaceutical company Novartis announced Tuesday that it had discontinued the development of two drugs -- the hepatitis C treatment Zalbin, and antifungal agent Mycograb. The company will take impairment charges of approximately $590 million in third quarter of 2010.

Roche's Avastin Fails in Early-Stage Colon Cancer Study

Roche's top-selling cancer-fighting drug Avastin has hit another roadblock in testing. In a Phase III study, Avastin failed to improve disease-free survival in early-stage colon cancer patients, the pharmaceutical giant reported.

FDA Sends Warning Letters to Electronic Cigarette Makers

The FDA issued warning letters to five electronic cigarette distributors, saying the products are being marketed illegally as safer alternatives to smoking and even as smoking-cessation aids. The agency says they must seek FDA approval in order to continue making those claims.

FDA Eyes Overhaul of Medical Device Regulation

The Food and Drug Administration is proposing to revamp its regulations of medical devices, the agency said Wednesday. While seeking to improve device safety, the FDA also wants to ease the regulatory environment and foster innovation. But the proposals have the industry concerned.

Weight-Loss-Drug Maker Vivus Soars on FDA Review

An expert panel will review Vivus' potential blockbuster drug Qnexa on Thursday, with the FDA making a decision in October. The FDA acknowledges the drug's effectiveness in cutting weight, but Qnexa will certainly draw scrutiny over its side effects.