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    1. KITE announced that its biologics license application (BLA) for its experimental CAR-T therapy, axicabtagene ciloleucel has been accepted for priority review by the FDA. The biotech companyis ...

    2. We remind investors that in May 2016, Intercept received FDA approval for Ocaliva, in combination with UDCA, for the treatment of PBC. In Dec 2016, Ocaliva was approved in the EU for ...

    3. The new FDA chief, who has said for weeks that his first priority will be the opioid problem, said that the agency can be most useful in stemming new addictions.

    4. Today, I sent an email to all of my colleagues at FDA, sharing with them the first steps I plan to take to better achieve this public health goal.

    5. Previous FDA commissioners have largely professed inability to act on drug costs, even as prices of drugs for cancer, hepatitis and other illnesses climbed to as much as hundreds of thousands ...

    6. Back in January, the FDA has finally acknowledged that some pacemakers and other cardiac devices are vulnerable to hacking. But how vulnerable are they, exactly? A security company called ...

    7. ‘‘Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use,’’ he wrote in ...

    8. A warning letter from the FDA in fall of 2014 limited Pacira to selling Exparel for bunions and hemorrhoids for about 15 months, Stack said. Pacira sued the FDA in late 2015, he ...

    9. INDUSTRY OVERVIEW TRT Market in a State of Flux List of FDA Approved TRTs by Formulation and Year of Approval Timeline for Launch of Various Types of Testosterone Replacement Therapies ...

    10. A live blog of the FDA's deliberations on neratinib, a breast cancer drug developed by Puma Biotechnology.

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