Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...
FDA approves new, non-opioid painkiller Journavx
The drug, shown to be almost as effective as opioids for short-term pain, is the first fundamentally new kind of painkiller ...
FDA approves first non-opioid pain medicine in more than 20 years
The Food and Drug Administration announced the approval of a new non-opioid pain medication this week, marking the first time ...
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under ...
The American Journal of Managed Care2h
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 ...
Healio3h
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
FDA Approves Non-Opioid Painkiller With No Addiction Risk
The Food and Drug Administration approved Vertex Pharmaceuticals’ “Journavx” on Thursday, greenlighting the non-opioid ...
STAT3d
How to protect HHS, FDA, NIH, and other health agencies from political interference
When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts ...
Rolling Out5d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
Renal & Urology News3d
Nasal Spray Formulation of Bumetanide Under FDA Review
A Prescription Drug User Fee Act target date of September 14, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application ...
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will ...
BioPharma Dive3d
Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research
Despite high demand for an option like Journavx, doctors fear the drug’s price could be a hangup for insurers and limit ...