Fda
FDA approves epinephrine nasal spray for children aged as young as 4 years
The FDA has approved neffy 1 mg epinephrine nasal spray for treating anaphylaxis and other type 1 allergic reactions in children aged 4 years and older, according to a press release from ARS Pharma.
FDA approves Encelto for macular telangiectasia type 2
The FDA approved Encelto, an encapsulated cell therapy, for the treatment of macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.
Two new denosumab biosimilars earn FDA approval
The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, according to a press release from Celltrion.
FDA approves TNKase for acute ischemic stroke in adults
The FDA has approved TNKase, a tissue plasminogen, clot-dissolving agent, to treat acute ischemic stroke in adults, according to the manufacturer.
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.