Vivus obesity drug has safety risks: FDA staff (Reuters)
Reuters – Vivus Inc’s obesity drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, U.S. drugs reviewers said.
Tag: FDA
FDA approves BioSante/Teva’s testosterone gel (Reuters)
Reuters – U.S. drug regulators approved a new testosterone gel from BioSante Pharmaceutical Inc and Teva Pharmaceuticals, a Food and Drug Administration spokeswoman said.
FDA panel votes against wider use of Amgen drug (Reuters)
Reuters – An advisory panel on Wednesday recommended that U.S. health regulators reject the use of Amgen Inc’s drug Xgeva to delay the spread of prostate cancer to the bone, dimming the chance of a wider use for one of the company’s key growth drivers.
Sanofi head-lice lotion wins FDA approval (Reuters)
Reuters – Sanofi said on Tuesday that the Food and Drug Administration had approved a lotion to treat head lice after clinical trials, which compared it with a placebo.
Roche breast cancer drug gets FDA priority review (Reuters)
Reuters – Health regulators granted a priority review for an experimental Roche breast cancer drug that in clinical trials added six months to the time before the disease worsened.
Orexigen, FDA agree on trial design for obesity drug (Reuters)
Reuters – Orexigen Therapeutics Inc said it reached an agreement with U.S. health regulators on the design of a heart-safety trial required for the approval of its experimental obesity drug.
FDA panel to discuss Arena obesity drug in 2nd quarter (Reuters)
Reuters – An FDA advisory committee will meet in the second quarter to discuss Arena Pharmaceutical Inc’s experimental obesity drug following the company’s recent resubmission of an application seeking its approval, Arena said on Wednesday.
FDA approves Roche skin cancer drug Erivedge (AP)
AP – Federal regulators on Monday approved a pill that treats the most common type of skin cancer, basal cell carcinoma.
Drug lobby wants clearer FDA rules for diet pills (Reuters)
Reuters – The pharmaceutical industry may stop investing in medicines to treat diseases like diabetes or obesity without more explicit guidelines from U.S. regulators, the chairman of the drug trade group said on Thursday.
BTG Wins Approval for Drug to Mitigate Toxic Cancer Medicine
Voraxaze is available in the US as part of a compassionate-use program under which the FDA allows patients with immediately life-threatening diseases access to alternative treatments on a case-by-case basis. The medicine brought in sales of $5.1 …
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FDA: Novartis recall may also affect painkillers (AP)
AP – The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant.
Senator warns FDA on danger of newest painkillers (AP)
AP – Following fatal shootings in two New York pharmacy robberies, a U.S. senator is warning that a new batch of “super painkillers” now under review could force repeats of recent violent robberies that left six people dead.