Food And Drug Administration

Food And Drug Administration News

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  Vivus Surges After Winning Support for First Weight-Loss Pill in 13 Years

  Updated 48 minutes ago

  Vivus Inc. more than doubled in early trading after the company’s weight-loss pill Qnexa won the backing of a U.S. advisory panel, moving a step closer to gaining approval as the first new obesity drug in 13 years.

• Ranbaxy Reports $606 Million Loss After U.S. Settlement

  Updated 19 minutes ago

  Ranbaxy Laboratories Ltd., India’s largest drugmaker, reported its biggest quarterly loss in at least four years, after the company took a $500 million charge to settle a legal dispute with U.S. authorities in December.

• Shire Wins EU Backing for U.S. Plant to Ease Drug Shortage

  Shire Plc won European Union health- regulator approval for a new U.S. factory that would boost output of medicines for rare genetic disorders, potentially hurting sales of rival treatments from Sanofi’s Genzyme unit.

• Can Fite Poised for Biggest Gain Since November

  Can Fite Biopharma Ltd. headed for the biggest gain since November after the the U.S. Food and Drug Administration gave its CF102 drug to treat primary liver cancer orphan status.

• Israel Stocks: Teva, D-Pharm, Can Fite, Partner, Cellcom, Camtek

  Israel’s TA-25 index declined for the first time in four days, sliding 0.1 percent to 1,118.62 at 1:40 p.m. in Tel Aviv.

• States With Raw-Milk Sales Have More Outbreaks, Study Shows

  States that allow raw milk sales have more than twice as many dairy-related disease outbreaks as states with prohibitions on such unpasteurized products, a Centers for Disease Control and Prevention study showed.

• Chelsea Therapeutics Northera Shouldn’t Be Approved on Safety, FDA Says

  Chelsea Therapeutics International Ltd.’s drug to treat a condition that can cause dizziness in people with nervous system disorders may be unsafe and shouldn’t be approved, U.S. regulators said. The company’s shares fell.

• Forest, Almirall Lung Drug May Be Tied to Cardiovascular Deaths, FDA Says

  Forest Laboratories Inc. and Almirall SA’s experimental drug to treat breathing complications tied to a common lung disease may be linked to more instances of cardiovascular deaths at higher doses, U.S. regulators said.

• Brightpoint, Brocade, Dell, La-Z-Boy, Texas Roadhouse: U.S. Equity Preview

  Shares of the following companies had unusual moves in U.S. trading. Stock symbols are in parentheses and prices are as of 4 p.m. in New York.

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  Cancer-Drug Shortages Targeted by Stopgap FDA Approval of Similar Products

  Cancer-drug shortages that have plagued U.S. hospitals are being targeted by Food and Drug Administration decisions, announced today, giving generic-drug makers clearance to provide stopgap replacements.

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