FDA Needs More Data on Sulopenem for Uncomplicated UTI
The NDA submission was supported by data from the phase 3 SURE1 clinical trial.
The NDA submission was supported by data from the phase 3 SURE1 clinical trial.
B-cell repopulation occurs more often in African American vs White patients between 6 and 12 months after anti-CD20 infusion
The approval was based on data from a study that compared 2 different maintenance dosages of Panzyga in 142 adults with CIDP.
After six to 12 months of treatment with the drug, patients no longer had amyloid protein plaques.
SLS-005 contains the active ingredient trehalose, a low molecular weight disaccharide that crosses the blood brain barrier, stabilizes proteins and activates autophagy.
Libervant is a buccally administered soluble film of diazepam used to treat acute uncontrolled seizures in patients with refractory epilepsy on stable AED regimens.
This week we have remdesivir news; A new opioid and spinal muscular atrophy treatments are approved; A sublingual epinephrine treatment; And the latest on Biogen’s investigational Alzheimer disease treatment. Also, we have a brief summary of the other drugs in the pipeline from the past week.
Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.