Jaymin Kang

Philadelphia

Drug Information Specialist at The Cardiology Advisor

Drug Information Specialist at Monthly Prescribing Reference

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Articles

Steqeyma 45mg/0.5mL Single-Dose Vial Option for Pediatric Use Approved

5 days ago | dermatologyadvisor.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis.
Twice-Yearly HIV-1 PrEP Yeztugo Gets FDA Approval

5 days ago | infectiousdiseaseadvisor.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg who are at risk for HIV-1 acquisition. Yeztugo is an HIV-1 capsid inhibitor with long-acting properties. It is available in both an injectable and tablet formulation. Initiation of Yeztugo involves use of both the tablet and injectable. Continued PrEP involves twice-yearly subcutaneous injections.
Twice-Yearly HIV-1 PrEP Yeztugo Gets FDA Approval

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg who are at risk for HIV-1 acquisition. Yeztugo is an HIV-1 capsid inhibitor with long-acting properties. It is available in both an injectable and tablet formulation. Initiation of Yeztugo involves use of both the tablet and injectable. Continued PrEP involves twice-yearly subcutaneous injections.
FDA to Review Novel Oral Antibiotic for Uncomplicated Gonorrhea

1 week ago | infectiousdiseaseadvisor.com | Jaymin Kang

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for zoliflodacin for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. Zoliflodacin is an oral spiropyrimidinetrione antibiotic with activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin (in vitro studies).
Patritumab Deruxtecan BLA Withdrawn After Missing Overall Survival Endpoint

1 week ago | pulmonologyadvisor.com | Jaymin Kang

Daiichi Sankyo and Merck have voluntarily withdrawn the Biologics License Application (BLA) for patritumab deruxtecan, an investigational human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate being investigated for previously-treated locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
FDA Approves Andembry for Prophylactic Use in Hereditary Angioedema

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Andembry® (garadacimab-gxii) for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Garadacimab, an activated Factor XII inhibitor, decreases the activation of prekallikrein to kallikrein and the production of bradykinin, both of which are associated with inflammation and swelling in HAE attacks.
Venetoclax Plus Azacitidine Misses in Treatment-Naïve, Higher-Risk MDS

1 week ago | empr.com | Jaymin Kang

Topline data were announced from a phase 3 trial evaluating venetoclax (Venclexta®) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The randomized, double-blind, phase 3 VERONA trial (ClinicalTrials.gov identifier: NCT04401748) evaluated the safety and efficacy of venetoclax, a B-cell lymphoma-2 inhibitor, with azacitidine, a pyrimidine nucleoside analog of cytidine, in treatment-naïve adults with higher-risk MDS.
Xifyrm Approved for Management of Moderate to Severe Pain

1 week ago | clinicalpainadvisor.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Xifyrm™ (meloxicam injection) for use in adults for the management of moderate to severe pain, alone or in combination with non-NSAID (non-steroidal anti-inflammatory) analgesics. Meloxicam, an NSAID, works by inhibiting cyclooxygenase 1 and 2, leading to analgesic, anti-inflammatory, and antipyretic effects.
Symbravo Now Available for the Acute Treatment of Migraine

1 week ago | clinicalpainadvisor.com | Jaymin Kang

Symbravo® (meloxicam and rizatriptan) is now available for the acute treatment of migraine with or without aura in adults. Symbravo is an oral agent that consists of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan, a 5-HT1B/1D agonist. The approval was supported by data from the phase 3 MOMENTUM (ClinicalTrials.gov Identifier: ) and INTERCEPT (ClinicalTrials.gov Identifier: ) trials.
Epinephrine Sublingual Film Under Review for Severe Allergic Reactions

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for epinephrine sublingual film (Anaphylm™) for the treatment of Type 1 allergic reactions, including anaphylaxis. Epinephrine sublingual film is an investigational polymer matrix-based epinephrine prodrug product.