FDA/CDC
FDA/CDC
FDA fast-tracks lecanemab for Alzheimer’s disease
The drug is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils.
FDA/CDC
FDA leader explains rationale leading to controversial Alzheimer’s drug approval
In view of the “fierce public debate” that erupted immediately following the drug’s approval, the FDA felt compelled to explain how it reached its...
FDA/CDC
FDA to add myocarditis warning to mRNA COVID-19 vaccines
But a CDC advisory panel, where the FDA made the announcement, still strongly backs the vaccines’ benefits, which outweigh the rare risk for heart...
FDA/CDC
FDA approves OTC antihistamine nasal spray
Nasal antihistamines “work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy...
News
Watchdog group demands removal of FDA leaders after aducanumab approval
“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” critic...
FDA/CDC
FDA: More metformin extended-release tablets recalled
FDA/CDC
FDA clears next-generation DBS system for movement disorders
“Until now, sensing capability and directional leads have not been available in the same DBS system.”
Latest News
FDA approves controversial Alzheimer’s drug aducanumab (Aduhelm)
Approval was granted despite an FDA advisory panel recommendation not to approve the drug.
FDA/CDC
FDA approves ‘game changer’ semaglutide for weight loss
Based on the STEP clinical trial results, the FDA has approved a 2.4 mg/week subcutaneous dose of the GLP-1 receptor agonist semaglutide (Wegovy,...
FDA/CDC
FDA approves ibrexafungerp for vaginal yeast infection
This is the first drug in a new antifungal class.