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 ...

No new safety or tolerability concerns were observed with Biktarvy during pregnancy and postpartum. The Food and Drug Administration (FDA) has approved updated labeling for Biktarvy ® (bictegravir ...

Results showed a reduction in annualized bleeding rate after a single infusion of fidanacogene elaparvovec compared with standard of care. The Food and Drug Administration (FDA) has approved Beqvez ™ ...

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 ...

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4 and vascular endothelial growth factor A. The Food and Drug Administration (FDA) has granted Fast Track designation to ...

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 ...

Credit: Takeda. The approval was based on data from the phase 3 VISIBLE 2 trial. Results showed 48% of patients treated with vedolizumab SC were in clinical remission at week 52 compared with 34% ...

Credit: Getty Images. The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack ...

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 ...

The deficiencies noted in the CRL were not related to efficacy or safety data. The Food and Drug Administration (FDA) has issued a Complete Response Letter to Abeona Therapeutics regarding the ...

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 ...

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 is ...