Fda
FDA recommends removing black box warning for CV risk from all testosterone product labels
The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the agency’s review of several studies, according to a release.
FDA grants orphan drug designation to porosome reconstitution therapy for cystic fibrosis
The FDA granted orphan drug designation to porosome reconstitution therapy for treating patients with cystic fibrosis, according to a press release from Porosome Therapeutics.
FDA cancels meeting to pick flu vaccine components for next season
The FDA canceled a meeting of vaccine advisors scheduled for next month to decide the composition of next season's influenza vaccines, an HHS official confirmed Thursday.
FDA grants fast track designation to phentolamine ophthalmic solution 0.75%
The FDA granted fast track designation to phentolamine ophthalmic solution 0.75% to treat significant chronic night driving impairment in patients who have undergone keratorefractive surgery.
‘Will make life better’: FDA advances Zoryve cream 0.05% for pediatric atopic dermatitis
The FDA has accepted the supplemental new drug application for Zoryve cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years, according to a press release from the manufacturer.
FDA approves first adaptive deep brain stimulation system for Parkinson’s disease
The FDA has approved BrainSense, an adaptive deep brain stimulation system that can adjust therapy for Parkinson’s disease in real time based on the patient’s brain activity, according to the manufacturer.
FDA approves rapid initiation of Sublocade for opioid use disorder
The FDA has approved label changes for once-monthly Sublocade, helping to reduce possible barriers to treatment initiation for opioid use disorder and speed up availability of treatment, according to a press release from the manufacturer.
FDA approves first treatment for rare lipid storage disease
The FDA has approved Ctexli for the treatment of cerebrotendinous xanthomatosis (CTX), a rare lipid storage disease, in adults.
FDA clears investigational new drug application for Zabalafin Hydrogel
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has been cleared by the FDA, Alphyn Biologics announced in a press release.
FDA removes semaglutide from drug shortage list
The FDA has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand, Novo Nordisk and the FDA announced.