AACR: Little benefit seen for cancer drugs given accelerated approval
Apr 08, 2024
Fewer than half of the cancer drugs granted accelerated approval demonstrate clinical benefit.
Gabapentinoids linked to increased risk for severe exacerbation in COPD
Jan 16, 2024
Compared with matched nonusers, gabapentinoid users have an increased risk across indications of epilepsy, neuropathic pain and other chronic pain.
FDA approves Rezdiffra for nonalcoholic steatohepatitis
Mar 15, 2024
Drug was approved on an ‘accelerated’ schedule due to pressing medical need
FDA approves Aurlumyn for severe frostbite
Feb 15, 2024
The newly approved medication lowers the need for amputation of fingers or toes.
FDA approves Wegovy to lower risk for CVD events in patients with obesity
Mar 08, 2024
Agency’s action could widen access to the drug if more insurance companies decide to cover it
Company seeks FDA approval for MDMA as treatment for PTSD
Dec 13, 2023
“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”
FDA approves topical treatment for molluscum contagiosum
Jul 24, 2023
Ycanth has been approved for adults and children older than 2 years.
FDA approves new antibiotic for three indications
Apr 08, 2024
Zevtera is approved for S. aureus bloodstream infections, acute bacterial skin/skin structure infections and bacterial pneumonia.
Expanded use of Xolair to treat food allergies approved by the FDA
Feb 17, 2024
Xolair is not meant to substitute for emergency anaphylaxis medications such as the EpiPen.
FDA approves Voquezna for erosive esophagitis, GERD
Nov 07, 2023
A Phase 3 trial showed noninferiority versus lansoprazole in healing and maintenance phases.