Credit: X4 Pharmaceuticals. The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 4WHILM trial. Findings showed mavorixafor was associated with statistically ...

Pharmacokinetic data indicate that in pediatric patients 2 to 5 years of age, administration of the buccal film is expected to provide adequate therapeutic exposures. The Food and Drug Administration ...

Results showed a reduction in annualized bleeding rate after a single infusion of fidanacogene elaparvovec compared with ...

The Food and Drug Administration (FDA) has approved Pivya (pivmecillinam) for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (UTIs) caused by ...

The nasal spray product delivers 10mg of naloxone hydrochloride in a single dose. The Food and Drug Administration (FDA) has approved Rezenopy (naloxone hydrochloride) nasal spray for the emergency ...

Compared with dupilumab, a significantly higher proportion of patients treated with upadacitinib achieved both EASI 90 and WP-NRS 0/1 at week 16. Among patients with moderate to severe atopic ...

Only the products and lot numbers listed are affected by this recall. EPI Health has initiated a voluntary recall of various within-expiry drug products as the Company has shut down operations and ...

Credit: Getty Images. A review of recent medical-related criminal activity related to the unlawful dispensing and distribution of prescription medications. Oncology Practice Pays Over $1 Million to ...

Ojemda is the first FDA-approved systemic therapy for pediatric LGG patients with BRAF rearrangements, including fusions. The Food and Drug Administration (FDA) has granted accelerated approval to ...

MamaLift Plus is the first prescription digital therapeutic to get FDA clearance for postpartum depression treatment. The Food and Drug Administration (FDA) has cleared MamaLift Plus, the first ...