STAT2h
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
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 ...
FDA approves Susvimo for diabetic macular edema
The U.S. Food and Drug Administration has approved Genentech's Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular ...
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 ...
How a Leftist Activist Group Helped Torpedo a Psychedelic Therapy
The fallout from the F.D.A.’s rejection of MDMA-assisted treatment for PTSD worries researchers and experts who fear other ...
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 ...
Hosted on MSN3d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...
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 ...
Hosted on MSN5d
New FDA Approval Could Transform Pain Management
It’s become a familiar tragedy: someone is prescribed pain medication to recover from an injury, then becomes addicted to the medication intended to improve their life. It’s left both healthcare ...
PBS6d
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 ...
FiercePharma6d
Axsome secures hard-fought FDA nod for rapid-acting migraine drug Symbravo
Meloxicam is a nonsteroidal, anti-inflammatory molecule developed with Axsome’s Molecular Solubility Enhanced Inclusion ...