Government
Three months after it won approval in type 2 diabetes, AstraZeneca’s Farxiga is eying potential regulatory win as a treatment in heart failure patients.
“We are pleased that the FDA recognized Molgradex as a breakthrough therapy for the treatment of aPAP, a debilitating rare lung disease with no approved pharmacologic treatment options,” said Rob Neville, Savara’s chief executive officer.
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.
Over the course of 2019, there have been numerous reports that show the increasing price of the medication is keeping it out of reach of patients. Some lawmakers are placing the blame squarely on the shoulders of drugmakers.
The clinical trials the approval is based on suggested the drug was effective for treating primary insomnia but may also be effective for insomnia associated with other diseases, such as depression.
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Alex Azar, Secretary of HHS.
With the latest approval, Xtandi, an androgen receptor inhibitor, is now the only oral treatment approved by the FDA for three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
The plan, put forth by House Speaker Nancy Pelosi, was passed last week on a mostly party-line vote, with support from two Republicans.
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