JD Supra1h
State Licensing Requirements: Are You Prepared?
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...
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 ...
federalnewsnetwork.com8d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex ...
The American Journal of Managed Care3d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Supernus: New Approval Holds Promise Of Increased Growth
Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...
Pharmaceutical Technology on MSN23h
FDA grants orphan drug status to Arbor Biotechnologies’ PH1
The FDA has granted orphan drug designation (ODD) and RPDD to Arbor Biotechnologies' ABO-101, to treat primary hyperoxaluria ...
What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of opioids.
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...