FDA plans to speed path to approval for some gene therapies, starting with hemophilia
(By Ike Swetlitz for STAT) WASHINGTON — The Food and Drug Administration will soon be alerting companies that certain gene
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Part D/Prescription Drugs
FDA’s strategic priorities for 2018 is advancing digital health technologies
One of the priorities this year for the FDA is advancing digital health technologies. FDA’s Center for Devices and Radiological
Read MoreCMS will no longer tolerate Medicare Part D gag clauses
As part of a larger federal effort, the Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma issued a
Read MoreALS patients losing time and hope as they wait for insurers to cover a pricey new drug
(By Ed Silverman for STAT) For the past two years, Sarah Benoit has been getting around with the help of
Read MoreNew Type Of Drug To Prevent Migraines Heads To Market
(By Richard Harris for NPR) The Food Drug Administration has approved a first-of-its-kind drug that reduces the number of migraines
Read MoreRight-to-try bill headed for vote puts bigger burden on FDA to protect patients, Gottlieb says
(By Ike Swetlitz and Erin Mershon for STAT) WHITE OAK, Md. — The House is set to take up a
Read MoreVermont Legislators Pass A Drug Importation Law. So What?
(By Shefali Luthra for Kaiser Health News) This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription
Read MoreFDA calls out 39 drug companies for allegedly blocking access to generics
(By Erin Mershon for STAT) Johnson & Johnson’s Actelion Pharmaceuticals, Celgene, and Gilead Life Sciences are all potentially blocking generic
Read MoreHow A Drugmaker Gamed The System To Keep Generic Competition Away
(By Alison Kodjak for NPR) When Celgene Corp. first started marketing the drug Revlimid to treat multiple myeloma in 2006,
Read MoreCMS is initiating a National Coverage Analysis for CAR-T therapies
In 2017, the Food and Drug Administration approved the first chimeric antigen receptor (CAR)-T cell therapies, now the Centers for
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