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Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.
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A $6.4 billion accord for U.S. drug and medical-device reviews is set to unravel just three months after taking effect as lawmakers squabble over budget cutbacks.
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Bristol-Myers Squibb Co. and AstraZeneca Plc.’s new diabetes pill will probably face increased scrutiny from regulators and doctors after two rivals were tied to cancer and heart risks.
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Johnson & Johnson and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.
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U.S. regulators haggling with medical-device makers over how much it will cost to speed up product reviews starting this year missed a legal deadline to submit a proposal for congressional approval.
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Congressional talks to renew the fees drugmakers pay to fund Food and Drug Administration reviews include proposals to fast-track evaluations of medicines for conditions with no approved cures, according to two U.S. Senate aides.
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Roche Holding AG may face long odds convincing a U.S. advisory panel to let the company’s top- selling drug Avastin be used against breast cancer.
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Makers of vaginally implanted surgical meshes, led by Johnson & Johnson, may have to conduct studies of three years or more on the products if the Food and Drug Administration follows an advisory panel’s lead.
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Arena Pharmaceuticals Inc. rose as much as 26 percent after the U.S. Food and Drug Administration said it “regrets” the lack of an animal toxicity expert on an advisory panel that rebuffed the obesity drug lorcaserin.
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Drugmakers such as Pfizer Inc. and Eli Lilly & Co. agreed with regulators on a 6 percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017.
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