Medical Regulatory Issues Headlines

  • U.S. FDA approves first two-drug HIV regimen in win for GSK

    (Reuters) - The U.S. Food and Drug Administration has approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines.

    in.reuters.com
  • U.S. FDA approves first two-drug HIV regimen from GSK

    NEW YORK (Reuters) - The U.S. Food and Drug Administration on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines.

    in.reuters.com
  • Cytokinetics sinks on abandoning ALS drug after failed trial

    (Reuters) - Cytokinetics Inc shares plummeted nearly 28 percent on Tuesday after the drugmaker said it would stop developing one of its treatments for ALS, a fatal neuro-degenerative disorder, after the drug failed to improve lung function in a key trial.

    in.reuters.com
  • U.S. FDA approves first two-drug HIV regimen

    NEW YORK (Reuters) - The U.S. Food and Drug Administration on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at easing the side effects for long-term patients who are on the standard treatment involving three or more drugs.

    in.reuters.com
  • Brexit gets real for drugmakers as regulator moves to Amsterdam

    LONDON (Reuters) - Drugmakers are racing to implement Brexit contingency plans to prepare for a jolt to their regulatory system as the European Medicines Agency is uprooted from London to Amsterdam.

    in.reuters.com
  • Cytokinetics abandons ALS drug after failed trial, shares tank

    (Reuters) - Cytokinetics Inc will stop developing one of its treatments for ALS, which afflicts Stephen Hawking, after the drug failed in a late-stage trial, the company said on Tuesday, sending its shares tumbling about 35 percent.

    in.reuters.com