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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.
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1 week ago | 
cancertherapyadvisor.com | Diana Ernst
The US Food and Drug Administration has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with unresectable or metastatic hepatocellular carcinoma (HCC). The approval was based on results from the phase 3 CheckMate-9DW trial. The trial (NCT04039607) was designed to compare nivolumab plus ipilimumab to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with advanced HCC who had not received prior systemic therapy.
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1 week ago | 
clinicaladvisor.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).
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1 week ago | 
clinicaladvisor.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.
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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).
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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.
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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).
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2 weeks ago | 
clinicalpainadvisor.com | Diana Ernst
The Food and Drug Administration (FDA) has expanded the approval of Dextenza® (dexamethasone ophthalmic insert) to include pediatric treatment. Specifically, the new indications include the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients; and the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older.
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2 weeks ago | 
empr.com | Diana Ernst
Topline results were announced from a phase 3 trial evaluating valiltramiprosate (ALZ-801) in apolipoprotein ε4 allele (APOE4) carriers with early Alzheimer disease (AD). Valiltramiprosate is an investigational oral agent designed to inhibit a key driver of cognitive decline in AD patients, the formation of soluble beta amyloid oligomers in the brain. Patients carrying 2 copies of the APOE4 gene (APOE4/4 homozygotes) are more likely to develop AD earlier in life than those without APOE4.
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2 weeks ago | 
empr.com | Diana Ernst
The Food and Drug Administration (FDA) has granted full approval to Vitrakvi® (larotrectinib) for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
