Healio1h
Researchers stress need for clear, consistent standards in FDA review of psychiatric drugs
The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...
AbbVie gets FDA approval for antibiotic treatment Emblaveo (update)
AbbVie (ABBV) said it has received FDA approval for the combination antibiotic treatment Emblaveo, which was co-developed ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
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 ...
stockhead3d
Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.
The American Journal of Managed Care4d
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 ...
FiercePharma4d
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
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 ...
BioSpace4d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
PBS7d
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The Food and Drug Administration approved the pill from Vertex Pharmaceuticals for acute pain that often occurs after surgery ...
NBC Los Angeles7d
FDA approves new type of nonopioid painkiller for acute pain
The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller from Vertex Pharmaceuticals, NBC ...