Monthly Prescribing Reference

6 days ago | empr.com | Steve Duffy

Pfizer ends danuglipron clinical program for obesity; FDA warns about counterfeit Ozempic; daily pill shows promise in reducing HbA1c; mavacamten misses in nonobstructive HCM trial and the FDA clears smart belt device reduce fall injury.

1 week ago | empr.com | Diana Ernst

Several hundred units of counterfeit Ozempic (semaglutide 1mg injection) were seized by the Food and Drug Administration (FDA), according to a drug safety alert issued by the Agency. The seized counterfeit products were distributed outside the Novo Nordisk authorized supply chain in the US. The products are labeled with an authentic lot number (lot number PAR0362) but include illegitimate serial numbers starting with the first eight digits 51746517.

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has granted Fast Track designation to VERVE-102 for the treatment of patients with hyperlipidemia and high lifetime cardiovascular risk to reduce low-density lipoprotein cholesterol (LDL-C). VERVE-102 is an in vivo base editing medicine designed to inactivate the PCSK9 (proprotein convertase subtilisin kexin type 9) gene. This is expected to disrupt the production of PCSK9 in the liver and ultimately reduce LDL-C levels in the bloodstream.

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved a prefilled syringe formulation of Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that allows patients to self-inject the medication. Vyvgart Hytrulo is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase. It is indicated for the treatment of adult patients with generalized myasthenia gravis (MG) who are anti-acetylcholine receptor antibody positive, and for adults with (CIDP).