Humira For Ulcerative Colitis Seems Headed Towards Approval, Many Post-market Studies
Unmet medical need for ulcerative colitis patients who have failed conventional therapy was enough to carry the day for Abbott’s drug at FDA’s Gastrointestinal Drugs Advisory Committee, but the optimal patient population and dose have not been established.
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Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.