FDA
The U.S. Food and Drug Administration will update its review process for the approval of medical devices in the wake of a report that showed more than 80,000 injuries have been associated with medical devices for pain management since 2008.
AbbVie could be eyeing another potential billion dollars of annual revenue following the accelerated approval of Venclexta for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or who cannot tolerate intensive chemotherapy.
The report, which was issued by the Council of Economic Advisors, pointed to changes in the approval process at the FDA in the approval process of generic drugs has led to greater competition in the marketplace, which has lowered the costs of the medications.
Sweden-based Sobi and Swiss-based Novimmune announced the U.S. approval of Gamifant (emapalumab-lzsg) to treat an ultra-rare disease in adults and children. Sobi’s U.S. offices are in Waltham, Mass.
YUPELRI (revefenacin) is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US
Modus Therapeutics AB announces that the FDA has accepted its sevuparin IND for the treatment of SCD.
The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.
Joseph Eid, head of medical at BMS, said Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the time a patient can live without the worsening of his or her disease.
According to the American Cancer Society, almost 601,000 people in the U.S. died of cancer in 2017. The two most common types of cancer are lung cancer and breast cancer, followed by colorectal cancer, prostate cancer and stomach cancer.
Two days after the FDA approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.
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