Brian Park, PharmD

The approval was based on data from three phase 3 trials which compared the efficacy of different dosing regimens of pivmecillinam to placebo, to another oral antibacterial drug, and to ibuprofen.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dostarlimab-gxly in combination with standard of care chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors. The sBLA is supported by data from part…

Sapropterin Dihydrochloride Powder for Oral Solution is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria.

MamaLift Plus is intended as an adjunct to clinician-managed outpatient care to provide neurobehavioral interventions to patients 22 years of age and older with mild to moderate PPD.

Ojemba is an oral, brain-penetrant, highly-selective type II RAF kinas inhibitor designed to target a key enzyme in the MAPK signaling pathway.

The expanded approval was based on PK, dosimetry, and safety data from the phase 2 NETTER-P study which included 9 pediatric patients, of which 4 patients had GEP-NETs.

Rilzabrutinib is an oral, reversible, covalent Bruton tyrosine kinase inhibitor.

At this time, there have been no reports of adverse events associated with this recall.

The approval was based on data from the phase 3 VISIBLE 2 trial.

The approval was based on data from the phase 3 ALINA study, which included 257 adults with ALK-positive NSCLC (tumors ≥4cm or node positive) following complete tumor resection.