FDA panel says Merck's sleep drug safe, effective at lower dose

The Maharashtra Food and Drug Administration (FDA) has decided to crack down on the cartelisation of the medicine and drug industry by asking companies to terminate their memorandums of understanding (MoU) in order to be able to manufacture drugs that are in ...

Excerpts from Reporter's Diary on CNBC-TV18 Watch the full show » Stung by the US FDA USD 500 million penalty, Japan's Diiachi Sankyo is exploring legal remedies to sue ex-Ranbaxy promoters, reports CNBC-TV18. Diiachi says that certain former ...

/PRNewswire/ -- Varian Medical Systems (NYSE:VAR) today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Varian's diagnostic X-ray image processing workstation that combines radio frequency (RF) and digital ...

Biopharmaceutical company Peregrine Pharmaceuticals (NASDAQ:PPHM) said on Monday that it has formed a collaboration with the US Food and Drug Administration (FDA) to proceed with a Phase III registration trial design of its lead clinical ...

WESTON, Mass. -- Specialty drugmaker Biogen Idec said Tuesday it submitted a new injectable multiple sclerosis drug to the Food and Drug Administration for U.S. market approval. The drug, called Plegridy, is intended to treat patients with relapsing ...

The health ministry decided not to toe the US FDA's line because of three reasons cited in a report prepared by Drug Controller General of India's office. NEW DELHI: The Indian government had in late 2008 probed the US Food and Drug Administration's charges ...

Hologic Inc. (HOLX: Quote) announced that the U.S. Food and Drug Administration or FDA approved the use of Hologic's new C-View 2D imaging software. The company said C-View 2D images may now be used in place of the conventional 2D exposure ...

FREDERICK, Md. "It's been 37 years since the FDA developed its medical device classification schema," Whelan said. "While the old classification of pulsed shortwave devices probably made sense in the 1970s, it is out of date in light of the dramatic ...

Jiangsu Hengrui Medicine Co., Ltd. (SHSE: 600276) revealed that a notice has been received from the Food and Drug Administration (FDA) saying that letrozole tablet produced by the company has gotten certification from the government agency and ...