Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
MedPage Today22 天
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate (HPC; Makena), which was approved in 2011 to reduce the risk of ...
BioSpace23 天
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
In a 32-page report, the Office of the Inspector General (OIG) flagged three drugs in particular—Biogen’s Alzheimer’s disease antibody Aduhelm (aducanumab), Sarepta’s Duchenne muscular dystrophy ...
precisionmedicineonline23 天
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm ...
In addition to Aduhelm, the OIG found concerning the FDA's accelerated approval of two other drugs, Sarepta Therapeutics' Exondys 51 (eteplirsen), an antisense oligonucleotide approved in 2016 to ...